FDA dashboard signals in 2017

Inspections

• 1036366 — Tuffy's Pet Foods, Inc. (NAI Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1036341 — Provimi de Puerto Rico, Inc. (VAI Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1039614 — BioLife Plasma Services L.P. (NAI Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1036565 — Octapharma Plasma, Inc. (VAI Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1040459 — Delta Air Lines (NAI Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1037969 — Amtrak National Railroad Passenger Corporation (NAI Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1038957 — Flowers Bakery Of Montgomery LLC (VAI Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1048439 — CSL Plasma, Inc. (NAI Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1038145 — JBS USA, LLC (NAI Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
• 1036651 — KC Classic Gourmet Foods, LLC (VAI Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

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Compliance actions

• Warning Letter — Transbuana international express (Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — PT. GALAXY NUSA DUA (Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — PT. Nusantara Jaya Abadi (Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — Continental Manufacturing Chemist, Inc. (Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — Exxon/Tiger Mart (Thu Dec 28 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — Dixie Mart (Thu Dec 28 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — Harrison Trading Post (Thu Dec 28 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — The Main Pub (Thu Dec 28 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — Citgo (Thu Dec 28 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
• Warning Letter — Cenex (Thu Dec 28 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recalls

• F-0641-2018 — Blommer Chocolate Company of California, LLC (Sun Dec 31 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
• F-0655-2018 — Lovebiotics, LLC (Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
• F-0696-2018 — Hong Chang Corporation (Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
• Z-0845-2018 — Toshiba American Medical Systems Inc (Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
• Z-0842-2018 — Toshiba American Medical Systems Inc (Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
• F-0654-2018 — Lovebiotics, LLC (Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
• Z-0843-2018 — Toshiba American Medical Systems Inc (Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
• Z-0844-2018 — Toshiba American Medical Systems Inc (Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
• D-0241-2018 — DLC Laboratories, Inc (Thu Dec 28 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
• Z-2313-2021 — Epimed International (Thu Dec 28 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

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Import refusals

• AEK-4068315-0/11/1 — KOWA CORPORATION (Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Japan)
• AEK-4068315-0/21/1 — Daiichi Sankyo Healthcare Co, LTD (Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Japan)
• AEK-4068315-0/41/1 — Lion Corporation (Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Japan)
• AEK-4068315-0/51/1 — Muhi Ikeda Mohando Co., Ltd. (Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Japan)
• AEK-4068315-0/31/1 — SATO HEALTHCARE INNOVATIONS (Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Japan)
• AEK-4068315-0/71/1 — MUNDI PHARMA (Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Japan)
• 799-3194338-2/11/1 — GUANGZHOU HUADU DISTRICT MEITON (Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — China)
• 799-3614220-4/11/1 — SHENZHEN DANIBOS C (Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — China)
• AEK-4068315-0/61/1 — Rohto Pharmaceutical Co Ltd (Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Japan)
• 879-0121143-0/11/1 — SHAHABUDDIN TRADING CO (Fri Dec 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — India)