FDA Inspection
Biomat USA, Inc.Biomat USA, Inc. – FDA Inspection, Jan 9, 2025
Record Details
This FDA Inspection record concerns Biomat USA, Inc., with an inspection on January 9, 2025, issued by the Denver District Office, covering biologics.
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ID · 1d0c4be5-f678-41ad-a309-6a86b7948f85
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1258091
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 606.60(a)Provide proper equipment to meet requirements
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Biomat USA, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 6, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA, Inc.
- FDA Inspection 1053346 - 2018-04-06
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