FDA Inspection 1259373 — Bora Pharmaceutical Services Inc.
The FDA completed an inspection of Bora Pharmaceutical Services Inc. on Jan 28, 2025 in Mississauga. 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). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 28, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mississauga (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 4328 | 21 CFR 211.122(a) | Written procedures not followed |
| 4369 | 21 CFR 211.188(b)(11) | Identification of persons involved, each significant step |