FDA Inspection
Biomat USA IncBiomat USA Inc – FDA Inspection, Sep 2, 2026
Record Details
This FDA Inspection record concerns Biomat USA Inc, with an inspection on September 2, 2026, issued by the Denver District Office, covering biologics.
- Office
- Denver District Office
- Person
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ID · 88274413-aad9-4710-b5c6-cf7ecbd43eaf
Inspection Facts
- Inspection number
- 1335102
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 630.10(e)(1)Medical Assessment Factors
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Other FDA inspections of Biomat USA Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 28, 2019 | Not classified | Denver District Office |
Other documents for Biomat USA Inc
- FDA Inspection 1091480 - 2019-03-28
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