FDA Inspections, Recalls & Compliance Actions in 2021

Inspections

• 1160037 — Peterson Farms, Inc. (NAI Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1158949 — Jans Enterprises Corp. dba WIRA Corp. (VAI Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1159939 — Maurice Pastries, LLC. (VAI Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1158984 — Muktanand Foods Inc (VAI Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1159850 — CK FOOD INC (NAI Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1159006 — Diamond Star LLC (VAI Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1160499 — Octapharma Plasma Inc (NAI Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1160781 — BioLife Plasma Services L.P. (NAI Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1159828 — Nodine's Smokehouse, Inc. (VAI Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1160771 — Bud's Best Cookies Inc (VAI Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))

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Compliance actions

• Warning Letter — DOLLAR GENERAL 12149 (Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — The Vineyard Liquors (Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — 7-Eleven (Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — C-Store/Conoco (Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — Family Dollar #4427 (Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — PaPa Z's / Jake's Market and Deli (Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — Sam's Food Stores/Citgo/Smoke Shop (Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — Shell (Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — Airline Deli (Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — Gasolinera Total Rio Canas (Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))

Recalls

• D-0371-2022 — Teva Pharmaceuticals USA (Fri Dec 31 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
• F-0740-2022 — Organic By Nature, Inc. (Fri Dec 31 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
• D-0362-2022 — Rubicon Research Private Limited (Fri Dec 31 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
• D-0370-2022 — Teva Pharmaceuticals USA (Fri Dec 31 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
• Z-0651-2022 — Howmedica Osteonics Corp. (Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
• Z-0732-2022 — RAYSEARCH LABORATORIES AB (Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
• D-0366-2022 — RemedyRepack Inc. (Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
• Z-0652-2022 — Howmedica Osteonics Corp. (Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
• F-0616-2022 — G&C Food Distributors & Brokers Inc. (Wed Dec 29 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
• F-0617-2022 — G&C Food Distributors & Brokers Inc. (Wed Dec 29 2021 00:00:00 GMT+0000 (Coordinated Universal Time))

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Import refusals

• 231-4242545-9/31/1 — Hai Son Foods Co. (Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Vietnam)
• F77-0034866-6/151/1B — Franemm Industries (Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Nigeria)
• INL-0222514-9/12/1 — QIANSHAN QINYUAN PACKAGING CO.,LTD (Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — China)
• 231-4242545-9/21/2 — Hai Son Foods Co. (Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Vietnam)
• F77-0034866-6/111/1E — Odabest Company (Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Nigeria)
• F77-0034866-6/151/1A — PZ Nigeria Limited (Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Nigeria)
• SCS-9312202-8/11/1 — SHENZHENSHIWENYEZHUANGSHISHEJIGONGC (Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — China)
• SCS-9226382-3/11/1 — Potentia Trium B.V (Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Netherlands)
• 231-4242545-9/21/1 — Hai Son Foods Co. (Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Vietnam)
• F77-0034866-6/151/1C — REMONIC MANUFACTURING (Thu Dec 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Nigeria)