FDA Inspection 976402 — Troy Manufacturing, Inc.
The FDA completed an inspection of Troy Manufacturing, Inc. on Jun 1, 2016 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 1, 2016
- Fiscal Year
- 2016
- 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 |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2402 | 21 CFR 211.194(a)(5) | Testing Calculations |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |