FDA Inspection
Bright Cell IncBright Cell Inc – FDA Inspection, May 15, 2026
Record Details
This FDA Inspection record concerns Bright Cell Inc, with an inspection on May 15, 2026, issued by the Los Angeles District Office, covering biologics.
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ID · 2c1f819b-c8dc-40ef-b063-fcdc31ff2b09
Inspection Facts
- Inspection number
- 1293606
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
15- 21 CFR 1271.50(b)(1)Donor screening standards
- 21 CFR 1271.55(a)(3)Summary--records used to make determination
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.130(c)Lot or control number assigned
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.192No written record of investigation
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