FDA Inspections, Recalls & Compliance Actions in 2018
FDA inspections, compliance actions, recalls, and import refusals recorded in 2018 — from official FDA enforcement data.
Inspections
- 1076964 — Apio, Inc. (NAI Dec 28, 2018)
- 1076265 — Tried And True Foods LLC (VAI Dec 28, 2018)
- 1076871 — Atherstone Foods, Inc. (NAI Dec 27, 2018)
- 1096516 — JP Surpass Trading Corp (VAI Dec 27, 2018)
- 1076112 — B & J Group (VAI Dec 27, 2018)
- 1077686 — Rispoli Farm, LLC (VAI Dec 27, 2018)
- 1076654 — Natural Organics, Inc. (NAI Dec 27, 2018)
- 1075802 — Central Bakery, Inc. (VAI Dec 27, 2018)
- 1075898 — B. Braun Medical, Inc. (VAI Dec 27, 2018)
- 1075598 — Delta Air Lines, Inc. (VAI Dec 26, 2018)
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Compliance actions
- Warning Letter — Merete GmbH (Dec 31, 2018)
- Warning Letter — Piece Of Mind (Dec 28, 2018)
- Warning Letter — Pavilions 3005 (Dec 28, 2018)
- Warning Letter — CUT RATE TOBACCO (Dec 27, 2018)
- Warning Letter — Rez Vape Shop (Dec 27, 2018)
- Warning Letter — Publix #446 (Dec 27, 2018)
- Warning Letter — QUICK SHOP MINIT MART 13 / SHELL (Dec 27, 2018)
- Warning Letter — PRIMO LIQUORS AND FINE WINE (Dec 27, 2018)
- Warning Letter — Puff N Pass / Smoke Shop (Dec 27, 2018)
- Warning Letter — Cenex / Ampride (Dec 27, 2018)
Recalls
- D-0364-2019 — Aurobindo Pharma USA Inc. (Dec 31, 2018)
- D-1035-2019 — Aurobindo Pharma USA Inc. (Dec 31, 2018)
- D-1039-2019 — Aurobindo Pharma USA Inc. (Dec 31, 2018)
- D-1036-2019 — Aurobindo Pharma USA Inc. (Dec 31, 2018)
- D-1038-2019 — Aurobindo Pharma USA Inc. (Dec 31, 2018)
- D-1037-2019 — Aurobindo Pharma USA Inc. (Dec 31, 2018)
- D-0370-2019 — Aurobindo Pharma USA Inc. (Dec 31, 2018)
- F-0842-2019 — Willamette Valley Pie Company, LLC. (Dec 31, 2018)
- D-0362-2019 — Aurobindo Pharma USA Inc. (Dec 31, 2018)
- D-0366-2019 — Aurobindo Pharma USA Inc. (Dec 31, 2018)
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Import refusals
- 231-6954069-2/11/3 — Flextronics Manufacturing Aguascalientes, SA De CV (Dec 31, 2018 — Mexico)
- KM6-3518375-9/11/1 — KOHINOOR FOODS LIMITED (Dec 31, 2018 — India)
- 231-6954069-2/11/2 — Flextronics Manufacturing Aguascalientes, SA De CV (Dec 31, 2018 — Mexico)
- 231-6954069-2/11/1 — Flextronics Manufacturing Aguascalientes, SA De CV (Dec 31, 2018 — Mexico)
- 231-6954069-2/11/4 — Flextronics Manufacturing Aguascalientes, SA De CV (Dec 31, 2018 — Mexico)
- H87-0235467-6/31/1 — Productos Agricola El Aguila SA De CV (Dec 31, 2018 — Mexico)
- SCS-2485093-6/11/1 — FURKAN YILDIZ (Dec 28, 2018 — Turkey)
- 9GK-0062947-1/11/1 — 2H NEW INTERNATIONAL LOGISTICS (Dec 28, 2018 — Vietnam)
- AEK-5388861-3/32/1 — SEEED TECHNOLOGY CO LTD (Dec 28, 2018 — China)
- WD8-0061553-2/111/5 — Naturelle LLC (Dec 28, 2018 — United Arab Emirates)