1062163
Westlab Pharmacy, Inc. dba Westlab Pharmacy — FEI 3007426960
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 |