FDA Inspection 869831 — Central Admixture Pharmacy Services, Inc.
The FDA completed an inspection of Central Admixture Pharmacy Services, Inc. on February 20, 2014 in Woburn, MA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 20, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Woburn, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1266 | 21 CFR 211.42(d) | Penicillin processing area not kept separate |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |