FDA Inspection 909759 — Pharmaceutica North America, Inc.
The FDA completed an inspection of Pharmaceutica North America, Inc. on Jan 6, 2015 in Glendale, CA. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 6, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Glendale, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 3641 | 21 CFR 211.204 | Record information inclusions |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |