FDA Inspection 635067 — Geritrex Corporation
The FDA completed an inspection of Geritrex Corporation on Dec 14, 2009 in Middletown, NY. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 14, 2009
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Middletown, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1456 | 21 CFR 211.115(b) | Reprocessing/quality control unit |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 3558 | 21 CFR 211.52 | Washing and toilet facilities not provided and accessible |