FDA Inspection 613331 — Chem-Tech, Ltd.
The FDA completed an inspection of Chem-Tech, Ltd. on September 18, 2009 in Pleasantville, IA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 18, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pleasantville, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1449 | 21 CFR 211.111 | Deviations of production time limits |
| 1774 | 21 CFR 211.142(a) | Quarantine - actual practice |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |