FDA Inspection 1080744 — Biocentric Lab LLC
The FDA completed an inspection of Biocentric Lab LLC on Feb 28, 2019 in Grapevine, TX. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 11 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Feb 28, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Grapevine, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12349 | 21 CFR 1271.190(c) | Control system |
| 12371 | 21 CFR 1271.200(a) | Cleaned, sanitized per established schedules |
| 12387 | 21 CFR 1271.220(a) | Causing contamination, increasing risks |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |
| 12401 | 21 CFR 1271.230(b) | Reduced risk representation |
| 12412 | 21 CFR 1271.260(b) | Storage temperatures appropriate |
| 12414 | 21 CFR 1271.260(d) | Corrective actions |
| 12426 | 21 CFR 1271.265(c)(2) | Improperly released for distribution |
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |
| 12435 | 21 CFR 1271.270(a) | Records maintained concurrently |