FDA Inspection 1163246 — Omega Alpha Pharmaceuticals
The FDA completed an inspection of Omega Alpha Pharmaceuticals on February 24, 2022 in Scarborough. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 24, 2022
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Scarborough (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 15434 | 21 CFR 111.15(d)(2) | Pest control measures |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15872 | 21 CFR 111.75(c)(3) | Specifications met identity,purity, strength, comp,; basis |
| 4464 | 21 CFR 108.25(c)(1) | Registration |
| 4470 | 21 CFR 108.25(c)(2) | Process filing |
| 4511 | 21 CFR 108.25(f) | Approved school |