FDA Inspection 1251950 — Pharmaceutics International Inc
The FDA completed an inspection of Pharmaceutics International Inc on Dec 6, 2024 in Hunt Valley, MD. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 6, 2024
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hunt Valley, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |