FDA Inspection
BIGFOOT BIOMEDICALBIGFOOT BIOMEDICAL – FDA Inspection, Mar 21, 2023
Record Details
This FDA Inspection record concerns BIGFOOT BIOMEDICAL, with an inspection on March 21, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b8844324-8233-44b7-a971-37ba9e418afd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1202522
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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