FDA Inspection
Biomat USA, Inc.Biomat USA, Inc. – FDA Inspection, Sep 22, 2017
Record Details
This FDA Inspection record concerns Biomat USA, Inc., with an inspection on September 22, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 30d5dfec-bd2a-44b3-9a14-b189f1d51c5e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1026545
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 606.40Clean & orderly
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 606.65(e)Following manufacturer's instructions
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Other FDA inspections of Biomat USA, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA, Inc.
- FDA Inspection 1256167 - 2024-11-15
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