FDA Inspection 1147167 — Colonia Care Pharmacy
The FDA completed an inspection of Colonia Care Pharmacy on July 26, 2021 in Colonia, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 26, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Colonia, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18936 | FDCA 501(a)(2)(A) | Non-microbial contamination, production area |
| 18939 | FDCA 501(a)(2)(A) | Highly potent drugs, prevention of cross-contamination |
| 18972 | FDCA 501(a)(2)(A) | Inadequate sporicidal agents, cleanroom and ISO 5 area |