FDA Inspection 1164537 — Expert Compounding Pharmacy
The FDA completed an inspection of Expert Compounding Pharmacy on Mar 4, 2022 in Lake Balboa, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 4, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lake Balboa, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 18936 | FDCA 501(a)(2)(A) | Non-microbial contamination, production area |
| 18938 | FDCA 501(a)(2)(A) | Hazardous drugs, prevention of cross-contamination |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 21377 | FDCA 501(a)(2)(A) | Use of non-pharmaceutical grade components |
| 4343 | 21 CFR 211.160(b)(1) | Incoming lots - conformance to written specs- |