FDA Inspection 632059 — Propack Contract Packaging Inc
The FDA completed an inspection of Propack Contract Packaging Inc on Nov 18, 2009 in High Ridge, 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). 16 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 18, 2009
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- High Ridge, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1168 | 21 CFR 211.34 | Consultant Records |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1797 | 21 CFR 211.82(a) | Examination on receipt, before acceptance |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4400 | 21 CFR 211.186(b)(8) | Description of containers, labels, et. al. |