FDA dashboard signals in 2020

Inspections

• 1135385 — COLLABORATIVE ADVANTAGE MARKETING dba CAM, LTD. (NAI Thu Dec 31 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1135387 — United Trading Inc. (NAI Wed Dec 30 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1134329 — ACRO International Food Distributors LLC (VAI Wed Dec 30 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1135554 — Q & H Trading Inc (NAI Wed Dec 30 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1135120 — General Air Service & Supply Co., Inc. (NAI Wed Dec 30 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1134302 — Santa Anita Foods Imports and Exports Inc (VAI Tue Dec 29 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1134287 — Mak Imports, LLC (VAI Tue Dec 29 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1134349 — MODERN VEG FARMS LLC (NAI Tue Dec 29 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1134919 — CEF ENTERPRISES INC (NAI Tue Dec 29 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1134296 — Alison R. Sehgal, MD (VAI Tue Dec 29 2020 00:00:00 GMT+0000 (Coordinated Universal Time))

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Compliance actions

• Warning Letter — Smarter Nutrition, Inc. (Mon Dec 28 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — Speedwinds Nutrition, Inc. (Tue Dec 22 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — New Leaf Pharmaceuticals (Tue Dec 22 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — NEXTL3VEL SERVICES GROUP LLC DBA ThisStuffIsGoodForYou (Tue Dec 22 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — G & L Wellness, LLC (Tue Dec 22 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — Bee Delightful (Tue Dec 22 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — Wellness BioSciences (Tue Dec 22 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — InfuScience, Inc. dba Bioscrip Infusion Services (Mon Dec 21 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — Riverstone LLC (Mon Dec 21 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — Sparrow Health & Performance LLC (Mon Dec 21 2020 00:00:00 GMT+0000 (Coordinated Universal Time))

Recalls

• F-0215-2021 — Rhino Foods, Inc. (Thu Dec 31 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
• Z-1120-2021 — Baxter Healthcare Corporation (Wed Dec 30 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
• Z-0875-2021 — Beckman Coulter Inc. (Wed Dec 30 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
• Z-1121-2021 — Baxter Healthcare Corporation (Wed Dec 30 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
• Z-1122-2021 — Baxter Healthcare Corporation (Wed Dec 30 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
• Z-1119-2021 — Baxter Healthcare Corporation (Wed Dec 30 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
• D-0233-2021 — Allergan, PLC. (Wed Dec 30 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
• F-0204-2021 — Ocean Providence Minneapolis LLC (Wed Dec 30 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
• D-0248-2021 — AuroMedics Pharma LLC (Wed Dec 30 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
• Z-1118-2021 — Baxter Healthcare Corporation (Wed Dec 30 2020 00:00:00 GMT+0000 (Coordinated Universal Time))

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Import refusals

• GP9-0007120-8/51/2 — GLAXO SMITH KLINE (Thu Dec 31 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — United Kingdom)
• SCS-3440909-6/11/1 — CERTUM DIAGNOSTICS (Thu Dec 31 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Mexico)
• 231-6875186-0/11/1 — SHANGHAI FOSUN LONG MARCH MEDICAL SCIENCE CO. LTD. (Thu Dec 31 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — China)
• 551-9694160-9/131/1 — KYRA ENTERPRISES (Thu Dec 31 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — India)
• 799-0165170-2/11/1 — ZYDUS HEALTHCARE (Thu Dec 31 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — India)
• SCS-3372617-7/11/1 — CELLRETURN CO LTD (Thu Dec 31 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — South Korea)
• SCS-1711435-8/11/1 — THAICOCO CO (Thu Dec 31 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Thailand)
• 879-4019794-7/61/4 — Produits Alimentaires Berthelet Inc. (Thu Dec 31 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Canada)
• 551-9694160-9/111/1 — KYRA ENTERPRISES (Thu Dec 31 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — India)
• 9ES-0056116-5/991/1 — MARUKO TSUKEMONO CO., LTD. (Thu Dec 31 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Japan)