FDA Inspection 733810 — Pure Chem Inc
The FDA completed an inspection of Pure Chem Inc on Jul 13, 2011 in Wentzville, MO. 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). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 13, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Wentzville, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4359 | 21 CFR 211.170(b)(1) | Retention time of reserve samples, in general |