FDA Inspection 987374 — Biomat USA, Inc.
The FDA completed an inspection of Biomat USA, Inc. on July 19, 2016 in Clearfield, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 19, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Clearfield, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 155 | 21 CFR 606.160(b) | Required records |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 18093 | 21 CFR 630.10(g)(1) | Proof Of Identity |
| 18094 | 21 CFR 630.10(g)(2) | Donor's Acknowledgment |
| 18116 | 21 CFR 630.30(a)(3) | Donor medical history |
| 299 | 21 CFR 640.66 | Immunization - physician eval, sched., & admin. |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 41 | 21 CFR 606.40(a)(1) | Provide space for examination |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |