inspection_id int64 | fei_number string | firm_name string | inspection_start_date null | inspection_end_date date32 | classification string | product_category string | citation_count int64 | cfr_violations string | citation_texts string | compliance_action_type string | compliance_action_date date32 | days_to_action float64 | related_drug_recall_numbers string | related_drug_recall_statuses string | related_drug_recall_count int64 | related_device_recall_numbers string | related_device_recall_count int64 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1,258,097 | 3009811895 | BISCUITERIE DE PROVENCE | null | 2024-11-21 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,042,486 | 3011817095 | H&C Food Inc. | null | 2018-01-26 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
759,071 | 3013914 | Bornstein Seafoods Inc | null | 2011-12-15 | Voluntary Action Indicated (VAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,059,282 | 2245539 | VLV Associates, Inc. | null | 2018-06-14 | No Action Indicated (NAI) | Devices | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
843,981 | 3001451379 | Greiner Bio-One North America, Inc. | null | 2013-07-24 | Voluntary Action Indicated (VAI) | Devices | 0 | null | null | null | null | null | null | null | 0 | Z-0835-2013 | 1 |
649,942 | 3005643967 | Demeter Transport, LLC | null | 2010-02-25 | No Action Indicated (NAI) | Veterinary | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,196,877 | 3011015097 | Prosidyan Inc | null | 2023-02-02 | No Action Indicated (NAI) | Devices | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
619,085 | 3004263507 | Central Coast Cooling, Inc. | null | 2009-09-23 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,045,491 | 1000102572 | Chrissa Imports Ltd* | null | 2018-03-06 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
829,643 | 2183870 | ev3 Inc. | null | 2013-04-29 | No Action Indicated (NAI) | Devices | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,058,475 | 1575443 | Community Blood Center | null | 2018-07-05 | No Action Indicated (NAI) | Biologics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
879,139 | 3010685855 | Kevin D. Cannon, M.D. | null | 2014-04-03 | No Action Indicated (NAI) | Drugs | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,050,986 | 3003048792 | Borealis Breads | null | 2018-05-02 | Voluntary Action Indicated (VAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
948,774 | 1925774 | CLA-COR Farms LLC | null | 2015-10-15 | Official Action Indicated (OAI) | Veterinary | 0 | null | null | Warning Letter | 2015-12-07 | 0 | null | null | 0 | null | 0 |
746,611 | 3081819 | Boyd Coffee Co | null | 2011-09-16 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
987,385 | 3008724689 | Comfortland Medical, Inc. | null | 2016-09-26 | No Action Indicated (NAI) | Devices | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
570,162 | 1270490 | Winchester Hospital, BB | null | 2009-03-17 | No Action Indicated (NAI) | Biologics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,092,615 | 3008778303 | Sabra Dipping Company, LLC | null | 2019-05-08 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,045,894 | 1921383 | Blendhouse Allerton,LLC | null | 2018-02-15 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,004,834 | 3010596852 | Micromar Industria E Comercio Ltda. | null | 2016-12-22 | No Action Indicated (NAI) | Devices | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
710,622 | 3000260979 | K & M Meat Co Inc dba K & M Food Service | null | 2010-10-13 | Voluntary Action Indicated (VAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
955,975 | 3010503509 | Farmers Elevator Co of Biggs & Easton | null | 2015-10-15 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
660,578 | 1000222037 | Noven Pharmaceuticals, Inc. | null | 2010-05-06 | Voluntary Action Indicated (VAI) | Drugs | 0 | null | null | null | null | null | D-1372-2012; D-1373-2012; D-1374-2012; D-1375-2012; D-1413-2012 | Terminated | 5 | null | 0 |
859,271 | 1000305328 | Farnam Companies, Inc. | null | 2013-12-20 | No Action Indicated (NAI) | Veterinary | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
697,066 | 2000018684 | Kelley Bean Co, Inc | null | 2010-11-09 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
936,830 | 3004112448 | Jewel Precision Sheet Metal & Machining Co, Inc. | null | 2015-07-27 | No Action Indicated (NAI) | Devices | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,069,464 | 3005401259 | Route 9 Cooperative | null | 2018-09-11 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,169,822 | 3016494 | J R Simplot Company Idaho Plant | null | 2022-05-04 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,051,949 | 3004539544 | Conexus Food Solutions | null | 2018-05-11 | Voluntary Action Indicated (VAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,015,377 | 3006484207 | Brovetto Dairy & Cheese House LLC | null | 2017-06-23 | Voluntary Action Indicated (VAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,028,392 | 3010609490 | The Commissary LLC | null | 2017-09-28 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
960,076 | 3009407861 | Olon S.p.A. | null | 2016-02-12 | Voluntary Action Indicated (VAI) | Drugs | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
723,398 | 1545 | Delta Synthetic Co., Ltd. | null | 2011-04-14 | Voluntary Action Indicated (VAI) | Veterinary | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,098,151 | 3001481152 | Randys Foods LLC | null | 2019-06-19 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
905,645 | 2474233 | New York Presbyterian Hospital-Columbia University Med. Ctr. | null | 2014-12-02 | Voluntary Action Indicated (VAI) | Biologics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,160,491 | 3017088503 | ADMA Bio Centers Georgia Inc | null | 2021-10-29 | No Action Indicated (NAI) | Biologics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,158,343 | 3004390125 | Pacific Packaging Concepts Inc. dba Fresh Start Vitamin Company | null | 2021-12-08 | Voluntary Action Indicated (VAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,179,622 | 3012145205 | Airbus Americas Inc. | null | 2022-09-02 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,037,063 | 3008177334 | Wellington Foods Incorporated | null | 2017-12-13 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,247,258 | 1937642 | United Airlines, Inc. | null | 2024-08-13 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,007,909 | 1420439 | Vogelzang, Nicholas J., M.D. | null | 2017-03-16 | No Action Indicated (NAI) | Drugs | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,114,067 | 2120246 | Sanimax USA LLC | null | 2019-12-17 | No Action Indicated (NAI) | Veterinary | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
919,564 | 2176201 | CSL Plasma Inc. | null | 2015-03-13 | No Action Indicated (NAI) | Biologics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,047,620 | 3004737812 | Empowered Products, Inc. | null | 2018-03-27 | No Action Indicated (NAI) | Devices | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,266,745 | 3014761179 | CANEL'S USA,LLC | null | 2025-04-14 | Voluntary Action Indicated (VAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,088,954 | 3014769967 | Emily L. Elliot, VMD | null | 2019-05-01 | No Action Indicated (NAI) | Veterinary | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
921,016 | 1620055 | Champion Feeders, LLC | null | 2015-03-17 | No Action Indicated (NAI) | Veterinary | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
789,213 | 1526531 | Steris Corporation | null | 2012-07-05 | No Action Indicated (NAI) | Devices | 0 | null | null | null | null | null | null | null | 0 | Z-0141-2014; Z-0478-2014; Z-0616-2014; Z-1166-2014; Z-1596-2013; Z-1786-2013; Z-1850-2014; Z-2026-2014; Z-2036-2014; Z-2263-2013; Z-2284-2012; Z-2426-2012 | 12 |
731,210 | 3008326622 | Pietz's Kuchen Kitchen & Specialities, LLP | null | 2011-06-16 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
545,190 | 3002861147 | Bywood Seafood LLC | null | 2008-10-22 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,230,638 | 3003279883 | Dorotea Holding Co, LLC dba Alamo Biologics; dba Precision Allograft Solutions; dba Biorepository, LLC | null | 2024-09-20 | No Action Indicated (NAI) | Biologics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
784,952 | 3001239184 | Cole Brothers Corporation | null | 2012-06-04 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,214,667 | 1049974 | Harris Teeter Distribution Ctr | null | 2023-08-14 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
903,187 | 1623530 | Savage Gulf Services, Ltd | null | 2014-11-06 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
813,070 | 3009835806 | AC Enterprises | null | 2013-01-11 | Voluntary Action Indicated (VAI) | Veterinary | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
864,100 | 3009428989 | Trigen Laboratories | null | 2014-01-29 | Voluntary Action Indicated (VAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
552,994 | 3003470187 | S. Serra Cheese Company | null | 2008-12-16 | Voluntary Action Indicated (VAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,261,471 | 2431866 | Impladent Ltd. | null | 2025-02-19 | No Action Indicated (NAI) | Biologics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,172,626 | 2510021 | The Hershey Company (Reese Plant) | null | 2022-06-15 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,091,750 | 3010686705 | THAI KAMEDA CO., LTD. | null | 2019-05-28 | Voluntary Action Indicated (VAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
825,187 | 1627356 | Carter BloodCare-Marshall Donor Center | null | 2013-03-28 | No Action Indicated (NAI) | Biologics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
770,440 | 1931012 | Heinold Hog Market | null | 2012-02-29 | Voluntary Action Indicated (VAI) | Veterinary | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,238,785 | 3008180040 | Tropicale Foods, LLC | null | 2024-09-13 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
906,470 | 3008563008 | Exela Pharma Sciences LLC | null | 2014-11-21 | Voluntary Action Indicated (VAI) | Drugs | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
824,603 | 3003821373 | Olson Feed Service, Inc. | null | 2013-03-25 | No Action Indicated (NAI) | Veterinary | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,263,998 | 1929517 | Bakery Project, Inc. | null | 2025-02-24 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,150,331 | 3015045255 | Stampede Culinary Partners, Inc. | null | 2021-08-30 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
608,350 | 3002836339 | Vericel Corporation | null | 2009-08-21 | Voluntary Action Indicated (VAI) | Biologics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,158,477 | 3013311530 | KBF INC | null | 2021-12-10 | Voluntary Action Indicated (VAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
997,717 | 3003105989 | DAIRY FARMS OF AMERICA (DFA) | null | 2017-01-05 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,172,430 | 3021820535 | Preetham Jetty, M.D. | null | 2022-05-27 | No Action Indicated (NAI) | Drugs | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
556,429 | 2116730 | Maple Grove Cheese Inc | null | 2009-01-14 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,287,436 | 3015550662 | E.N.D. Imports Inc. | null | 2025-10-14 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,059,213 | 3004248759 | Payson Fruit Growers, Inc. | null | 2018-07-18 | Voluntary Action Indicated (VAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
587,910 | 3017067 | Johnson Foods, Inc. | null | 2008-11-18 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
912,758 | 3006378892 | Lavazza Professional North America | null | 2015-01-29 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,180,644 | 3000939342 | Keystone Protein Company | null | 2022-09-22 | No Action Indicated (NAI) | Veterinary | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,205,614 | 3007728475 | Minh Phung, Inc. | null | 2023-05-04 | Voluntary Action Indicated (VAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,227,761 | 3017600835 | Donggang Wanrui Food Co., Ltd. | null | 2024-01-22 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | Warning Letter | 2024-06-25 | 0 | null | null | 0 | null | 0 |
1,076,423 | 1419391 | HOOPESTON FOODS, INC | null | 2019-01-09 | Voluntary Action Indicated (VAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,035,711 | 3012349378 | Braeburn Pharmaceuticals Inc. | null | 2017-11-28 | No Action Indicated (NAI) | Drugs | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,058,470 | 1240239 | Massachusetts Maritime Academy | null | 2018-06-25 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,025,149 | 1049223 | Ethicon, Inc. | null | 2017-09-14 | Voluntary Action Indicated (VAI) | Devices | 0 | null | null | null | null | null | null | null | 0 | Z-0048-2020; Z-0693-2018; Z-0747-2019; Z-1135-2019; Z-1136-2019; Z-1147-2018; Z-1334-2020; Z-1335-2020; Z-1338-2018; Z-1340-2018; Z-1534-2018; Z-1841-2019; Z-2448-2018; Z-2450-2018; Z-2451-2018; Z-2453-2018; Z-2455-2018; Z-2458-2018; Z-2459-2018; Z-2463-2018; Z-2464-2018; Z-2465-2018; Z-2532-2018; Z-2533-2018; Z-2534-2018 | 25 |
1,204,894 | 1482496 | Milano Bakery Inc | null | 2023-05-02 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
854,638 | 3008802810 | Licht Far East (Singapore) Pte Ltd | null | 2013-06-13 | Official Action Indicated (OAI) | Drugs | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,217,487 | 3009840486 | Rostein, Daniel MD SC | null | 2023-09-11 | No Action Indicated (NAI) | Biologics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
685,506 | 3008538229 | Cai Li, Ph.D | null | 2010-10-18 | No Action Indicated (NAI) | Devices | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,084,417 | 2519047 | B & A Seafood, Inc. | null | 2018-11-02 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
953,336 | 3009784323 | Cardinal Health 414 LLC | null | 2015-09-29 | No Action Indicated (NAI) | Drugs | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
892,987 | 1000138760 | De La Garza Wholsale Dist | null | 2014-08-22 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,198,184 | 3011752157 | Advanced Dispersed Particles, SL. | null | 2022-05-05 | Voluntary Action Indicated (VAI) | Drugs | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,205,975 | 3014477031 | Apitoria Pharma Private Limited | null | 2023-05-19 | Voluntary Action Indicated (VAI) | Drugs | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,244,033 | 3002807114 | GlaxoSmithKline Manufacturing S.p.A. | null | 2023-10-26 | Voluntary Action Indicated (VAI) | Drugs | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
886,142 | 3010818122 | Koueido (Koeido Ltd. Kawara Plant) | null | 2014-06-06 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,293,808 | 3013155188 | Viander Inc | null | 2025-12-01 | No Action Indicated (NAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,039,491 | 3014142638 | Nazeeh N. Hanna, MD | null | 2018-02-01 | Voluntary Action Indicated (VAI) | Drugs | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
764,424 | 1672331 | Carter BloodCare - Tyler | null | 2012-01-20 | Voluntary Action Indicated (VAI) | Biologics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,121,361 | 3010071461 | Dairy Veterinary Services, Inc | null | 2020-01-30 | No Action Indicated (NAI) | Veterinary | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
1,157,829 | 3014613443 | LATIN PRODUCE LLC | null | 2021-12-01 | Voluntary Action Indicated (VAI) | Food/Cosmetics | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
754,552 | 3000210620 | Jant Pharmacal Corporation | null | 2011-11-08 | No Action Indicated (NAI) | Devices | 0 | null | null | null | null | null | null | null | 0 | null | 0 |
End of preview. Expand
in Data Studio
YAML Metadata Warning: empty or missing yaml metadata in repo card (https://huggingface.co/docs/hub/datasets-cards)
FDA Enforcement Linkage Dataset
A pre-joined, analysis-ready dataset connecting FDA inspection outcomes to enforcement actions, regulatory citations, and product recalls — covering 265,000+ inspections across 129,000+ facilities from 2008 to present.
Why This Dataset Exists
FDA publishes inspection, citation, compliance, and recall data across 4-5 separate databases with no common key. Researchers, compliance teams, and analysts must manually cross-reference these systems to answer basic questions like:
- What happened after a facility failed an inspection?
- How long does FDA take to issue a Warning Letter after an OAI classification?
- Which CFR violations most frequently lead to recalls?
This dataset joins those sources into a single flat file.
Schema
| Column | Type | Description |
|---|---|---|
inspection_id |
int | DDAPI inspection identifier |
fei_number |
str | FDA Establishment Identifier |
firm_name |
str | Inspected facility name |
inspection_start_date |
date | Inspection start |
inspection_end_date |
date | Inspection end |
classification |
str | NAI / VAI / OAI |
product_category |
str | Drugs, Food/Cosmetics, Devices, Veterinary, etc. |
citation_count |
int | Number of CFR citations for this inspection |
cfr_violations |
str | Semicolon-delimited CFR references (e.g., "21 CFR 211.68(a)") |
citation_texts |
str | Full citation text descriptions |
compliance_action_type |
str | Warning Letter / Injunction / Seizure (null if none) |
compliance_action_date |
date | Date enforcement action was taken |
days_to_action |
int | Days between inspection end and enforcement action |
related_drug_recall_numbers |
str | Drug recall numbers within ±6mo–2yr of inspection |
related_drug_recall_statuses |
str | Status of related drug recalls |
related_drug_recall_count |
int | Count of related drug recalls |
related_device_recall_numbers |
str | Device recall numbers linked by firm + timing |
related_device_recall_count |
int | Count of related device recalls |
Coverage
- 265,000+ inspection records
- 129,000+ unique facilities (by FEI number)
- 10,000+ Official Action Indicated (OAI) inspections
- 8,300+ inspections linked to compliance actions
- 4,000+ inspections linked to recalls
- Date range: October 2008 – present
- Update frequency: Quarterly
Sources
All data derived from public FDA databases:
- DDAPI Inspections & Classifications
- DDAPI Inspection Citations
- DDAPI Compliance Actions
- OpenFDA Drug Recalls
- OpenFDA Device Recalls
Methodology
- Inspections linked to citations via
inspection_id - Compliance actions linked to inspections via
fei_number+ time proximity (action within 2 years of inspection end) - Drug recalls linked via normalized firm name + time proximity (±6 months to 2 years)
- Device recalls linked via normalized firm name + time proximity (±6 months to 2 years)
Sample
The _sample file contains a random 10% subset for evaluation purposes.
License
Derived from U.S. government public data. The underlying data is in the public domain. This compiled and linked dataset is provided as-is.
Purchase
For the full dataset: https://mandiasdata.gumroad.com/l/fda-enforcement-linkage
- Downloads last month
- 5