FDA Inspection
NeoCells, LLCNeoCells, LLC – FDA Inspection, Jun 17, 2009
Record Details
This FDA Inspection record concerns NeoCells, LLC, with an inspection on June 17, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- NeoCells, LLC
- Inspection Date
- June 17, 2009
- Product Type
- Biologics
View Company Profile
ID · b87d9382-f34e-4981-9da1-ce8df233e05c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 590681
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.210(d)(1)Receipt documentation maintained
- 21 CFR 1271.160(c)Quality audits performed periodically
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.270(a)Records incomplete
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