FDA Inspection
NexCell Scientific IncNexCell Scientific Inc – FDA Inspection, Feb 5, 2026
Record Details
This FDA Inspection record concerns NexCell Scientific Inc, with an inspection on February 5, 2026, issued by the Los Angeles District Office, covering biologics.
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ID · 247a8bda-0b82-45fc-9984-10e2fa51cf7e
Inspection Facts
- Inspection number
- 1301380
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
18- 21 CFR 1271.47(a)Design of procedures to ensure compliance
- 21 CFR 1271.50(a)Responsible person to determine, document
- 21 CFR 1271.55(a)(3)Summary--records used to make determination
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.85(b)(2)SOP for release; reactive for CMV
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.150(b)Recall facilitation
- 21 CFR 211.188Prepared for each batch, include complete information
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