FDA Inspection 1251763 — Bactolac Pharmaceutical, Inc.
The FDA completed an inspection of Bactolac Pharmaceutical, Inc. on Feb 7, 2025 in Hauppauge, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 7, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Hauppauge, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15434 | 21 CFR 111.15(d)(2) | Pest control measures |
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22864 | 21 CFR 111.75(c)(3) | Specifications met identity, purity, strength, comp,; basis |