FDA Inspection
ALLORX LLCALLORX LLC – FDA Inspection, Jul 22, 2011
Record Details
This FDA Inspection record concerns ALLORX LLC, with an inspection on July 22, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- ALLORX LLC
- Inspection Date
- July 22, 2011
- Product Type
- Biologics
View Company Profile
ID · 7e2db1cc-999d-45b3-bb51-9adc9d959ed2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 736370
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
12- 21 CFR 1271.180(d)Adopted from another organization
- 21 CFR 1271.200(e)Documentation of maintenance and cleaning
- 21 CFR 1271.190(d)(2)Documentation of activities
- 21 CFR 1271.290(a)HCT/Ps not tracked
- 21 CFR 1271.160(c)Quality audits performed periodically
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.180(b)Review and approval-responsible person
- 21 CFR 1271.265(f)Return to inventory--procedures
- 21 CFR 1271.190(d)(1)Procedures for cleaning, sanitation
- 21 CFR 1271.200(b)Procedures inadequate
Showing 10 of 12 citations.
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.