FDA Inspection 1082195 — Bernz Medical Sales LLC
The FDA completed an inspection of Bernz Medical Sales LLC on Mar 11, 2019 in Ewa Beach, HI. 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 11, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Ewa Beach, HI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |