FDA Inspection
Cercle Allocation ServicesCercle Allocation Services – FDA Inspection, May 1, 2009
Record Details
This FDA Inspection record concerns Cercle Allocation Services, with an inspection on May 1, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Cercle Allocation Services
- Inspection Date
- May 1, 2009
- Product Type
- Biologics
View Company Profile
ID · 6d640a5d-e597-4923-abeb-e683b88203df
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 580235
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
10- 21 CFR 1271.290(b)Establishing a system
- 21 CFR 1271.210(d)(1)Receipt documentation maintained
- 21 CFR 1271.60(c)(3)Statement of restrictions
- 21 CFR 1271.250(b)Verification of label accuracy, legibility, integrity
- 21 CFR 1271.160(c)Quality audits performed periodically
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.200(b)Procedures inadequate
- 21 CFR 1271.210(a)Use prior to verification
- 21 CFR 1271.160(b)(2)(ii)Other establishments--mfg steps same HCT/P
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.