FDA Inspection 1164759 — Abbott Laboratories
The FDA completed an inspection of Abbott Laboratories on March 18, 2022 in Sturgis, MI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 18, 2022
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Sturgis, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18658 | 21 CFR 106.10(b)(1) | Personnel - clean outer garments, protective apparel |
| 18691 | 21 CFR 106.30(b) | Equipment, utensil - clean, sanitize |
| 18776 | 21 CFR 106.55(a) | System of process controls to prevent adulteration |
| 18899 | 21 CFR 106.100(k)(2) | Complaint investigation - hazard determination |