FDA Inspection 1168587 — Lynn Oaks Compounding Pharmacy
The FDA completed an inspection of Lynn Oaks Compounding Pharmacy on Apr 15, 2022 in Thousand Oaks, 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 15, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Thousand Oaks, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 18933 | FDCA 501(a)(2)(A) | Vermin, production area |
| 18938 | FDCA 501(a)(2)(A) | Hazardous drugs, prevention of cross-contamination |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 21377 | FDCA 501(a)(2)(A) | Use of non-pharmaceutical grade components |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |