FDA Inspection
Biocompatibles Inc.Biocompatibles Inc. – FDA Inspection, Apr 3, 2013
Record Details
This FDA Inspection record concerns Biocompatibles Inc., with an inspection on April 3, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Biocompatibles Inc.
- Inspection Date
- April 3, 2013
- Product Type
- Devices
View Company Profile
ID · 31ee179f-654c-4325-96dc-0c2b6f79a4ed
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 826953
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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