FDA Inspection
Antibodies IncAntibodies Inc – FDA Inspection, Mar 10, 2023
Record Details
This FDA Inspection record concerns Antibodies Inc, with an inspection on March 10, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
View Company Profile
ID · bb0be9e5-5db4-4895-8c60-7bc1c631a744
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1199455
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.70(g)(2)Periodic equipment inspections
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality audits - auditor independence
Showing 10 of 12 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Antibodies Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 21, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Antibodies Inc
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.