FDA Inspection 678212 — Troy Manufacturing, Inc.
The FDA completed an inspection of Troy Manufacturing, Inc. on Aug 30, 2010 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
- Aug 30, 2010
- Fiscal Year
- 2010
- 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 |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2020 | 21 CFR 211.188(b)(8) | Labeling Control Records and Label Copies |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |