FDA Inspection 965271 — Chem-Tech, Ltd.
The FDA completed an inspection of Chem-Tech, Ltd. on December 11, 2015 in Pleasantville, IA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 11, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pleasantville, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1388 | 21 CFR 211.101(d) | Component addition checked by 2nd person |
| 2016 | 21 CFR 211.188(b)(4) | Weights and Measures of Components Used |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |