FDA Inspection 1062163 — Westlab Pharmacy, Inc. dba Westlab Pharmacy
The FDA completed an inspection of Westlab Pharmacy, Inc. dba Westlab Pharmacy on August 15, 2018 in Gainesville, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 15, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Gainesville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 18944 | FDCA 501(a)(2)(A) | Exposure of personnel in aspectic processing |
| 18953 | FDCA 501(a)(2)(A) | Actionable microbial contamination, ISO 5 area |
| 18956 | FDCA 501(a)(2)(A) | Cleanliness, ISO-classified areas |
| 18959 | FDCA 501(a)(2)(A) | Location, ISO 5 classified area |
| 18970 | FDCA 501(a)(2)(A) | Disinfecting and cleaning agents, ISO 5 area |
| 21377 | FDCA 501(a)(2)(A) | Use of non-pharmaceutical grade components |