FDA Inspection
CorCell Companies, IncCorCell Companies, Inc – FDA Inspection, Mar 3, 2009
Record Details
This FDA Inspection record concerns CorCell Companies, Inc, with an inspection on March 3, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- CorCell Companies, Inc
- Inspection Date
- March 3, 2009
- Product Type
- Biologics
View Company Profile
ID · 1681ef7a-22a5-4e69-8f7e-c17b0474d6d7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 567606
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
7- 21 CFR 1271.160(a)Program is appropriate for the HCT/Ps
- 21 CFR 1271.85(b)(2)SOP for release; reactive for CMV
- 21 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
- 21 CFR 1271.75(b)Risk factors, leukocyte-rich cells or tissues
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.160(d)Validation for intended use
- 21 CFR 1271.160(b)(2)Procedures for complaints and other information
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.