FDA Inspection 1110608 — Medcore Biologix LLC
The FDA completed an inspection of Medcore Biologix LLC on Nov 19, 2019 in San Antonio, TX. 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 19, 2019
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- San Antonio, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12326 | 21 CFR 1271.160(c) | Quality audits performed periodically |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |