FDA Inspections, Recalls & Compliance Actions in 2023

Inspections

• 1227032 — Medstar Speciality Hospital (NAI Sat Dec 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1227197 — Nebraska Organ Recovery System d.b.a. Live On Nebraska (NAI Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1226443 — P & A BLUE FISH INC (VAI Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1226855 — Kimball A. Johnson, M.D. (NAI Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1226410 — Ralphs Riverside Distribution Center (NAI Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1226786 — Chris Engebose (NAI Thu Dec 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1226769 — Dairyland Veterinary Service (NAI Thu Dec 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1226549 — Neris Bakery Products Inc (NAI Thu Dec 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1221517 — BOFAS COMPANY LIMITED DBA Ser-U Ghana Market (VAI Thu Dec 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1226340 — ESM, Inc. dba Nimbl Fulfillment (NAI Thu Dec 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))

View more

Compliance actions

• Warning Letter — MarketPlace (Thu Dec 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — Citgo / Gladeville Grocery (Thu Dec 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — Ecomaxx (Thu Dec 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — Walgreens (Thu Dec 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — Tobacco and Vape (Thu Dec 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — JAYZ LIQUORS (Thu Dec 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — Karim Service Station (Thu Dec 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — Raceway 6814 (Thu Dec 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — TAYLOR SMOKE AND VAPE (Thu Dec 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — Adairville BP (Thu Dec 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))

Recalls

• F-0809-2024 — Mead Johnson & Company LLC (Sat Dec 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
• D-0237-2024 — Ascend Laboratories, LLC (Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
• F-0805-2024 — Ocean Group Inc. (Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
• Z-0776-2024 — Datex-Ohmeda, Inc. (Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
• D-0222-2024 — Rising Pharma Holding, Inc. (Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
• Z-0867-2024 — Aesculap Inc (Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
• Z-0775-2024 — Datex-Ohmeda, Inc. (Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
• Z-0866-2024 — Aesculap Inc (Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
• Z-0774-2024 — Datex-Ohmeda, Inc. (Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
• F-1114-2024 — Samsung Bean Sprout (Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time))

View more

Import refusals

• W69-5045942-1/11/1 — Da Cheng Vegetarian International Co., Ltd. (Sat Dec 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Taiwan)
• W69-5045942-1/81/1 — Da Cheng Vegetarian International Co., Ltd. (Sat Dec 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Taiwan)
• W69-5045942-1/91/1 — Da Cheng Vegetarian International Co., Ltd. (Sat Dec 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Taiwan)
• 9RN-1211641-1/11/1B — H Cosmetics Ci Srl (Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Ivory Coast)
• 264-2042870-3/21/1 — Empaque Rio Colorado SPR de RL de CV (Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Mexico)
• 438-0076814-5/11/1 — BORINQUEN SA (Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Nicaragua)
• KM6-3611133-8/81/1C — Dharya Enterprise (Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — India)
• W69-5041193-5/21/1 — Da Cheng Vegetarian International Co., Ltd. (Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Taiwan)
• KM6-3611133-8/81/1B — Dharya Enterprise (Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — India)
• W69-5041193-5/11/1 — Da Cheng Vegetarian International Co., Ltd. (Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Taiwan)