FDA Inspection
Biomat USABiomat USA – FDA Inspection, Jul 11, 2024
Record Details
This FDA Inspection record concerns Biomat USA, with an inspection on July 11, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.
View Company Profile
ID · 71d0e39b-4829-4296-b7b6-8896106a4143
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1243776
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 606.160(d)Retention period
- 21 CFR 606.160(a)(1)Concurrent documentation
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.