FDA Inspection 818919 — Central Admixture Pharmacy Services Inc.
The FDA completed an inspection of Central Admixture Pharmacy Services Inc. on Feb 22, 2013 in Chicago, IL. 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 22, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1433 | 21 CFR 211.42(c)(10)(iii) | Air Supply |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |