FDA Inspection
Biometrics Ltd.FDA Inspection 939511 - Biometrics Ltd. - January 22, 2015
Record Details
This FDA Inspection record concerns Biometrics Ltd., with an inspection on January 22, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Biometrics Ltd.
- Inspection Date
- January 22, 2015
- Product Type
- Devices
View Company Profile
ID · 204f35a5-83d0-4c51-98e1-809961444add
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 939511
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
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Other FDA inspections of Biometrics Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 13, 2018 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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