FDA Inspection 1157351 — Biocentric Lab LLC
The FDA completed an inspection of Biocentric Lab LLC on Nov 10, 2021 in Grapevine, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 12 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Nov 10, 2021
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Grapevine, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 15025 | 21 CFR 1271.85(b)(2) | Cytomegalovirus (CMV) |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |