FDA Inspection 1083750 — CMC Enterprise Pharmacy
The FDA completed an inspection of CMC Enterprise Pharmacy on March 22, 2019 in Charlotte, NC. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 22, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Charlotte, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18941 | FDCA 501(a)(2)(A) | Improper gowning, contamination |
| 18944 | FDCA 501(a)(2)(A) | Exposure of personnel in aspectic processing |
| 18956 | FDCA 501(a)(2)(A) | Cleanliness, ISO-classified areas |
| 18960 | FDCA 501(a)(2)(A) | Flow of personnel and materials, facility |
| 18961 | FDCA 501(a)(2)(A) | Air flow quality, higher classified area |
| 18963 | FDCA 501(a)(2)(A) | Inadequate HEPA filter, sterile product area |
| 18973 | FDCA 501(a)(2)(A) | Disinfecting materials, aseptic processing area |
| 21284 | FDCA 501(a)(2)(A) | Disinfectant contact time |