FDA Inspection
Biomat USA, Inc.Biomat USA, Inc. – FDA Inspection, Jul 19, 2016
Record Details
This FDA Inspection record concerns Biomat USA, Inc., with an inspection on July 19, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA, Inc.
- Inspection Date
- July 19, 2016
- Product Type
- Biologics
View Company Profile
ID · 636edbce-1706-4731-a5c9-6b218c5ee9b0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 987374
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
9- 21 CFR 640.66Immunization - physician eval, sched., & admin.
- 21 CFR 630.30(a)(3)Donor medical history
- 21 CFR 606.160(b)Required records
- 21 CFR 630.10(g)(1)Proof Of Identity
- 21 CFR 606.40(a)(1)Provide space for examination
- 21 CFR 630.10(g)(2)Donor"s Acknowledgment
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.20(b)Qualifications of responsible personnel
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Biomat USA, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 23, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 30, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA, Inc.
- FDA Inspection 1106116 - 2019-08-23
- FDA Inspection 797005 - 2012-08-30
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