FDA Inspection 819009 — Troy Manufacturing, Inc.
The FDA completed an inspection of Troy Manufacturing, Inc. on Feb 12, 2013 in Hazle Township, PA. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 12, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hazle Township, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |