FDA Inspection
BC3 TECHNOLOGIESFDA Inspection 1255718 - BC3 TECHNOLOGIES - November 26, 2024
Record Details
This FDA Inspection record concerns BC3 TECHNOLOGIES, with an inspection on November 26, 2024, issued by the Center for Devices and Radiological Health, covering medical devices & rad health.
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ID · c6e37c8a-7d21-4b43-8b55-d1eb6ac896f6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1255718
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
8- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.130Packaging
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.198(e)Maintained
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
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