FDA Inspection 1157283 — Bactolac Pharmaceutical, Inc.
The FDA completed an inspection of Bactolac Pharmaceutical, Inc. on November 19, 2021 in Hauppauge, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 19, 2021
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Hauppauge, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15673 | 21 CFR 111.315(a) | Criteria for establishing specifications |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |