FDA Inspection 1209511 — BHC, LLC
The FDA completed an inspection of BHC, LLC on Jun 30, 2023 in Brownsburg, IN. 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 30, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Brownsburg, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12222 | 21 CFR 1271.47(a) | Design of procedures to ensure compliance |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12272 | 21 CFR 1271.65(b)(2) | Labeled re: biohazard, risks, test results |
| 12274 | 21 CFR 1271.65(b)(3) | Physician notification (limited use) |
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |
| 12475 | 21 CFR 1271.370(a) | Clear and accurate label |