FDA Inspection 1089129 — Coast Quality Pharmacy, LLC
The FDA completed an inspection of Coast Quality Pharmacy, LLC on May 9, 2019 in Tampa, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 9, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 18954 | FDCA 501(a)(2)(A) | Actionable microbial contamination, adjacent area |
| 18970 | FDCA 501(a)(2)(A) | Disinfecting and cleaning agents, ISO 5 area |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 21377 | FDCA 501(a)(2)(A) | Use of non-pharmaceutical grade components |