File size: 9,976 Bytes
e776799 | 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 | fei_number,legal_name,city,state,country,product_types,total_inspections,oai_count,vai_count,nai_count,most_recent_inspection_date,most_recent_classification,most_recent_classification_code,warning_letter_count,recall_count,import_refusal_count,total_citations,distinct_cfr_codes,repeat_citation_flag,most_cited_cfr,ever_escalated_to_wl,fastest_escalation_days,has_510k_clearance,count_510k,facility_risk_score
3011988868,"Davis Ventures, Inc.",Wheat Ridge,Colorado,United States,[Food/Cosmetics],8,6,1,2,2021-08-19,Voluntary Action Indicated (VAI),VAI,2,0,0,32,23,true,21 CFR 111.103,true,110,false,0,100.0
3004007943,"A.P. Deauville, LLC",Easton,Pennsylvania,United States,"[Food/Cosmetics, Drugs]",7,3,4,0,2025-01-23,Official Action Indicated (OAI),OAI,1,4,0,70,31,true,21 CFR 211.25(a),true,190,false,0,100.0
3008472092,Mexicali Cheese Corp.,Woodhaven,New York,United States,[Food/Cosmetics],5,5,0,0,2012-07-06,Official Action Indicated (OAI),OAI,1,0,0,26,16,true,21 CFR 110.35(a),true,49,false,0,100.0
2021236,"B. Braun US Pharmaceutical Manufacturing, LLC",Irvine,California,United States,"[Drugs, Devices, Biologics]",15,3,8,4,2025-11-21,Official Action Indicated (OAI),OAI,1,0,18,38,27,true,21 CFR 211.192,true,366,false,0,100.0
1000028052,"Syfrett Feed Company, Inc.",Okeechobee,Florida,United States,[Veterinary],10,7,2,1,2024-08-28,Voluntary Action Indicated (VAI),VAI,1,0,0,21,11,true,21 CFR 225.180,true,187,false,0,100.0
3006031801,US Compounding Inc,Conway,Arkansas,United States,[Drugs],4,3,1,0,2019-02-07,Official Action Indicated (OAI),OAI,1,65,0,18,15,true,21 CFR 211.113(b),true,452,false,0,100.0
1036352,VistaPharm LLC,Largo,Florida,United States,[Drugs],11,1,7,3,2024-04-17,No Action Indicated (NAI),NAI,0,36,0,10,10,false,21 CFR 211.22(d),false,,false,0,100.0
3002495042,SEDECAL SA,Algete,,Spain,[Devices],3,1,1,2,2025-01-24,Official Action Indicated (OAI),OAI,0,53,2,6,5,false,21 CFR 820.30(g),false,,false,0,100.0
1000025822,Dairy Feeds Inc,Okeechobee,Florida,United States,[Veterinary],5,3,0,2,2023-08-24,Official Action Indicated (OAI),OAI,1,0,0,8,6,true,21 CFR 507.25(b)(2),true,219,false,0,95.0
1000139071,"El Gordo Spices, LLC",Dallas,Texas,United States,[Food/Cosmetics],10,4,5,1,2023-03-22,Voluntary Action Indicated (VAI),VAI,1,0,0,23,18,true,21 CFR 123.6(b),true,77,false,0,92.0
1000069719,"Williams & Son Livestock, LLC.",London,Kentucky,United States,[Veterinary],7,4,1,2,2023-07-27,Official Action Indicated (OAI),OAI,0,0,0,8,2,true,n/a,false,,false,0,90.0
1000115118,"Del Rey Tortilleria, Inc.",Chicago,Illinois,United States,[Food/Cosmetics],5,4,0,1,2011-01-27,Official Action Indicated (OAI),OAI,0,0,0,41,33,true,21 CFR 110.20(b)(4),true,57,false,0,85.0
2000020397,"Create-A-Pack Foods, Inc.",Ixonia,Wisconsin,United States,[Food/Cosmetics],13,2,8,3,2025-02-19,No Action Indicated (NAI),NAI,2,0,0,88,67,true,21 CFR 111.70(e),true,160,false,0,80.0
1000115331,Pioneer Surgical Technology Inc.,Marquette,Michigan,United States,"[Devices, Biologics]",11,1,6,8,2024-06-14,Voluntary Action Indicated (VAI),VAI,1,3,0,29,21,true,21 CFR 820.75(a),true,103,false,0,80.0
3004218330,"Longway Farms, LLC",Swanton,Vermont,United States,[Veterinary],2,2,0,0,2015-04-09,Official Action Indicated (OAI),OAI,1,0,0,10,5,true,FDCA 501(a)(5),true,43,false,0,75.0
1000113338,"Global Source Management & Consulting, Inc",Tamarac,Florida,United States,"[Drugs, Food/Cosmetics]",2,2,0,0,2013-08-20,Official Action Indicated (OAI),OAI,1,0,0,19,18,true,21 CFR 111.83(a),true,179,false,0,75.0
1000513191,"Lyne Laboratories, Inc.",Brockton,Massachusetts,United States,"[Food/Cosmetics, Drugs]",10,1,7,2,2026-03-10,Voluntary Action Indicated (VAI),VAI,0,4,0,36,27,true,21 CFR 211.100(a),false,,false,0,75.0
1000121041,Conair LLC,Stamford,Connecticut,United States,[Devices],6,2,2,4,2025-10-22,Voluntary Action Indicated (VAI),VAI,1,0,0,18,13,true,21 CFR 820.100(a),true,73,false,0,70.0
3004464535,McCallum Manufacturing Limited,Barnsley,,United Kingdom,[Drugs],2,2,0,0,2023-09-15,Official Action Indicated (OAI),OAI,1,0,0,0,0,false,,true,257,false,0,70.0
1048788,Pharmco Laboratories Inc.,Titusville,Florida,United States,"[Drugs, Food/Cosmetics]",5,2,2,1,2025-03-20,Voluntary Action Indicated (VAI),VAI,1,0,2,29,22,true,21 CFR 211.160(b),true,381,false,0,69.0
1000100754,Berkeley Biologics LLC,Richmond,California,United States,[Biologics],5,1,1,3,2023-09-25,Official Action Indicated (OAI),OAI,1,0,0,8,7,true,21 CFR 1271.230(a),true,277,false,0,65.0
1619734,"W.H. Braum, Inc.",Tuttle,Oklahoma,United States,"[Veterinary, Food/Cosmetics]",11,2,4,5,2024-03-07,Voluntary Action Indicated (VAI),VAI,1,0,0,24,15,true,21 CFR 530.11(d),true,74,false,0,65.0
3005698871,Landy International,Xia Men,,China,[Drugs],2,1,1,0,2023-12-14,Official Action Indicated (OAI),OAI,1,0,5,9,8,false,21 CFR 211.67(a),true,181,false,0,65.0
1000113729,"Denterprise International, Inc.",Ormond Beach,Florida,United States,[Devices],4,2,3,1,2021-08-19,Voluntary Action Indicated (VAI),VAI,1,0,0,35,22,true,21 CFR 820.80(a),true,156,false,0,62.0
1416923,"Deibel Laboratories of Illinois, Inc.",Lincolnwood,Illinois,United States,"[Food/Cosmetics, Drugs, Veterinary, Devices]",5,2,1,4,2017-03-23,Voluntary Action Indicated (VAI),VAI,1,0,0,27,15,true,21 CFR 211.165(b),true,133,false,0,60.0
3010450840,"Specialty Medicine Compounding Pharmacy, P.C.",South Lyon,Michigan,United States,[Drugs],1,1,0,0,2013-11-05,Official Action Indicated (OAI),OAI,1,1,0,6,6,false,21 CFR 211.67(a),true,664,false,0,60.0
1000050126,"Persimmon Hill Farm Gourmet Foods, Inc",Lampe,Missouri,United States,[Food/Cosmetics],6,2,2,2,2024-09-19,No Action Indicated (NAI),NAI,1,0,0,22,13,true,21 CFR 114.100(a),true,106,false,0,60.0
3002807663,Beckman Coulter Mishima K.K.,Sunto-Gun,,Japan,[Devices],1,0,1,0,2014-01-30,Voluntary Action Indicated (VAI),VAI,0,6,0,0,0,false,,false,,false,0,60.0
3005692119,"E and M Bakery, Inc.",Hialeah,Florida,United States,[Food/Cosmetics],4,2,2,3,2011-07-21,No Action Indicated (NAI),NAI,1,0,0,25,14,true,21 CFR 123.11(b),true,127,false,0,60.0
1000268398,LEVO AG,Wohlen Ag,,Switzerland,[Devices],1,1,0,0,2025-04-09,Official Action Indicated (OAI),OAI,1,0,1,5,5,false,21 CFR 820.198(a),true,98,false,0,57.0
2123036,"Puris Proteins, LLC.",Dawson,Minnesota,United States,[Food/Cosmetics],10,1,5,4,2025-08-01,Voluntary Action Indicated (VAI),VAI,1,0,0,33,23,true,21 CFR 113.100(a),true,136,false,0,55.0
3004269506,"Yuyao City Boss Vegetable Factory Co., Ltd.",Ningbo,,China,[Food/Cosmetics],1,1,0,1,2025-06-17,No Action Indicated (NAI),NAI,1,0,11,0,0,false,,true,164,false,0,55.0
3009350497,China Pharmaceutical University,Nanjing,,China,[Drugs],2,1,1,0,2024-09-20,Official Action Indicated (OAI),OAI,1,0,0,7,7,false,21 CFR 211.22(a),true,125,false,0,55.0
1000111057,"ForYou, Incorporated",Loris,South Carolina,United States,[Food/Cosmetics],4,1,3,0,2026-04-29,Voluntary Action Indicated (VAI),VAI,1,0,0,20,14,true,21 CFR 111.535(b)(1),true,242,false,0,55.0
3013863863,"Coastal E-Liquid Laboratory, LLC",Diberville,Mississippi,United States,[Tobacco],2,1,0,1,2024-05-16,Official Action Indicated (OAI),OAI,1,0,0,0,0,false,,false,,false,0,55.0
1000122287,Allied Vision Group Inc,Fort Lauderdale,Florida,United States,[Devices],3,2,1,0,2022-04-22,Voluntary Action Indicated (VAI),VAI,0,1,1,21,10,true,21 CFR 820.160(b),false,,false,0,54.0
1629694,Professional Compounding Centers of America,Houston,Texas,United States,[Drugs],6,2,2,2,2023-04-21,Voluntary Action Indicated (VAI),VAI,1,0,0,3,3,false,21 CFR 211.100(b),true,436,false,0,52.0
1000086682,Lifeline Systems Company,Framingham,Massachusetts,United States,[Devices],4,0,3,3,2022-08-17,Voluntary Action Indicated (VAI),VAI,0,3,10,4,3,false,21 CFR 820.198(a),false,,false,0,52.0
3005962855,"Walk, Ed",Neoga,Illinois,United States,[Veterinary],1,1,0,0,2012-11-15,Official Action Indicated (OAI),OAI,1,0,0,0,0,false,,true,69,false,0,50.0
3009442128,Snellman Farms,Mcconnelsville,Ohio,United States,[Veterinary],1,1,0,0,2012-03-09,Official Action Indicated (OAI),OAI,1,0,0,2,2,false,21 CFR 530.11(d),true,84,false,0,50.0
3004407329,Coast IRB LLC,Colorado Springs,Colorado,United States,[Drugs],1,1,0,0,2009-04-29,Official Action Indicated (OAI),OAI,1,0,0,7,7,false,21 CFR 56.115(a)(6),false,,false,0,50.0
3011656880,PCP LV LLC dba Pinnacle Compounding Pharmacy,Las Vegas,Nevada,United States,[Drugs],1,1,0,0,2015-07-31,Official Action Indicated (OAI),OAI,1,0,0,11,11,false,21 CFR 211.113(b),true,297,false,0,50.0
3001452193,"Venus Foods, Inc",City Of Industry,California,United States,[Food/Cosmetics],8,1,6,1,2023-08-04,Voluntary Action Indicated (VAI),VAI,1,0,0,33,13,true,21 CFR 123.11(b),true,136,false,0,50.0
1000086892,Moniz Dairy Farm,Tiverton,Rhode Island,United States,[Veterinary],1,1,0,0,2012-01-31,Official Action Indicated (OAI),OAI,1,0,0,3,3,false,FDCA 501(a)(5),true,45,false,0,50.0
3003481016,Soleetech Corporation,Taipei,,Taiwan,[Devices],1,1,0,0,2013-05-15,Official Action Indicated (OAI),OAI,1,0,0,9,9,false,21 CFR 820.40,true,90,false,0,50.0
3007453404,"Huyard, Christian M.",Christiana,Pennsylvania,United States,[Veterinary],1,1,0,0,2009-07-30,Official Action Indicated (OAI),OAI,1,0,0,4,2,false,21 CFR 530.11(a),true,197,false,0,50.0
3008534521,GOLDEN MEDAL MUSHROOM INC,Commerce,California,United States,[Food/Cosmetics],1,1,0,0,2021-05-18,Official Action Indicated (OAI),OAI,1,0,0,1,1,false,21 CFR 1.502(a),true,163,false,0,50.0
3010796560,Lynn Born,Follett,Texas,United States,[Veterinary],1,1,0,0,2014-06-12,Official Action Indicated (OAI),OAI,1,0,0,3,3,false,21 CFR 530.41(a),true,70,false,0,50.0
3010107364,"Bleu Ribbon Delicacies, LLC dba Native Cure",North Hollywood,California,United States,[Food/Cosmetics],5,1,4,0,2024-03-06,Voluntary Action Indicated (VAI),VAI,1,0,0,29,14,true,21 CFR 123.6(c)(2),true,190,false,0,50.0
1319182,Glottal Enterprises Inc.,Syracuse,New York,United States,[Devices],5,1,2,4,2024-10-17,Voluntary Action Indicated (VAI),VAI,1,0,0,12,11,true,21 CFR 820.80(e),true,187,false,0,50.0
|