FDA Inspection 1038075 — College Pharmacy, Inc.
The FDA completed an inspection of College Pharmacy, Inc. on January 17, 2018 in Colorado Springs, CO. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 17, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Colorado Springs, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18938 | FDCA 501(a)(2)(A) | Hazardous drugs, prevention of cross-contamination |
| 18939 | FDCA 501(a)(2)(A) | Highly potent drugs, prevention of cross-contamination |
| 18941 | FDCA 501(a)(2)(A) | Improper gowning, contamination |
| 18953 | FDCA 501(a)(2)(A) | Actionable microbial contamination, ISO 5 area |
| 18956 | FDCA 501(a)(2)(A) | Cleanliness, ISO-classified areas |
| 18970 | FDCA 501(a)(2)(A) | Disinfecting and cleaning agents, ISO 5 area |