FDA Inspection 775163 — World Gen, LLC
The FDA completed an inspection of World Gen, LLC on Mar 7, 2012 in Hamilton, 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 7, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hamilton, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |