FDA Inspection 785856 — Seyer Pharmatec, Inc.
The FDA completed an inspection of Seyer Pharmatec, Inc. on Jun 11, 2012 in Caguas, PR. 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 11, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Caguas, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |