FDA Inspection 883358 — Central Admixture Pharmacy Services, Inc.
The FDA completed an inspection of Central Admixture Pharmacy Services, Inc. on June 11, 2014 in Allentown, PA. 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
- June 11, 2014
- Fiscal Year
- 2014
- 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 |
| 1174 | 21 CFR 211.42(b) | Product flow through building is inadequate |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |