FDA Inspection 914112 — Central Admixture Pharmacy Services, Inc.
The FDA completed an inspection of Central Admixture Pharmacy Services, Inc. on Feb 11, 2015 in Allentown, PA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Feb 11, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Allentown, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4366 | 21 CFR 211.188(a) | Accurate reproduction included |