803394
Accupack Midwest Inc — FEI 1000122754
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 11, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cincinnati, OH (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 |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1927 | 21 CFR 211.166(b) | Accelerated stability studies |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3611 | 21 CFR 211.160(b)(3) | Acceptance of drug products |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4350 | 21 CFR 211.160(b)(3) | Drug products-sampling procedures/specifications |