FDA Inspection 598717 — Central Admixture Pharmacy Services Inc
The FDA completed an inspection of Central Admixture Pharmacy Services Inc on July 10, 2009 in Homewood, AL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 23 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 10, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Homewood, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1728 | 21 CFR 211.87 | Retest of approved components/containers/closures |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1797 | 21 CFR 211.82(a) | Examination on receipt, before acceptance |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 1868 | 21 CFR 211.94(b) | Protection from external factors |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1918 | 21 CFR 211.166(a)(2) | Stability sample storage conditions described |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 6705 | 21 CFR 310.305(c) | Failure to submit ADE report |