FDA Inspection 1039787 — Geritrex Corporation
The FDA completed an inspection of Geritrex Corporation on Feb 2, 2018 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 2, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Middletown, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1 | 21 CFR 11 | Electronic records |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1545 | 21 CFR 211.125(c) | Label reconciliation discrepancies evaluation/investigation |
| 1868 | 21 CFR 211.94(b) | Protection from external factors |
| 3592 | 21 CFR 211.110(c) | In-process materials characteristics testing |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |