FDA Inspection
Biodominium DiagnosticsBiodominium Diagnostics – FDA Inspection, Aug 12, 2022
Record Details
This FDA Inspection record concerns Biodominium Diagnostics, with an inspection on August 12, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Biodominium Diagnostics
- Inspection Date
- August 12, 2022
- Product Type
- Devices
View Company Profile
ID · c70b9099-2d90-4ca3-bbea-1ff6d189d802
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1178174
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
12- 21 CFR 820.80(e)Documentation
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 809.10(a)(5)Reagent storage instructions--protect stability
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
Showing 10 of 12 citations.
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.