FDA Inspection
Biocentric Lab LLCBiocentric Lab LLC – FDA Inspection, Feb 28, 2019
Record Details
This FDA Inspection record concerns Biocentric Lab LLC, with an inspection on February 28, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 545c6c54-eb69-45db-8528-a8f2a588a971
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1080744
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
11- 21 CFR 1271.260(d)Corrective actions
- 21 CFR 1271.200(a)Cleaned, sanitized per established schedules
- 21 CFR 1271.265(c)(2)Improperly released for distribution
- 21 CFR 1271.220(a)Causing contamination, increasing risks
- 21 CFR 1271.260(b)Storage temperatures appropriate
- 21 CFR 1271.190(c)Control system
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.265(e)Procedures and release criteria
- 21 CFR 1271.230(a)Validation & approval--established procedures
- 21 CFR 1271.270(a)Records maintained concurrently
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Other FDA inspections of Biocentric Lab LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 11, 2026 | Not classified | Dallas District Office | Human Cellular, Tissue, and Gene Therapies |
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