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 devices.
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ID · 079e54df-4b1c-4f5d-822b-b3094b9b1f1f
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
- Compliance: 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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