FDA Inspection 749979 — Chem-Tech, Ltd.
The FDA completed an inspection of Chem-Tech, Ltd. on October 19, 2011 in Pleasantville, IA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 19, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pleasantville, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1918 | 21 CFR 211.166(a)(2) | Stability sample storage conditions described |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |