FDA Inspection 1051024 — Coast Quality Pharmacy, LLC
The FDA completed an inspection of Coast Quality Pharmacy, LLC on May 7, 2018 in Tampa, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 7, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1433 | 21 CFR 211.42(c)(10)(iii) | Air Supply |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 18941 | FDCA 501(a)(2)(A) | Improper gowning, contamination |
| 18948 | FDCA 501(a)(2)(A) | Disruption of airflow from personnel movement |
| 18953 | FDCA 501(a)(2)(A) | Actionable microbial contamination, ISO 5 area |
| 18957 | FDCA 501(a)(2)(A) | Dust-collecting overhangs, surrounding area of ISO 5 |
| 18973 | FDCA 501(a)(2)(A) | Disinfecting materials, aseptic processing area |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 21377 | FDCA 501(a)(2)(A) | Use of non-pharmaceutical grade components |