ENABLE BIOSCIENCES – FDA Inspection, Oct 17, 2024

Record Details

This FDA Inspection record concerns ENABLE BIOSCIENCES, with an inspection on October 17, 2024, issued by the San Francisco District Office, covering medical devices & rad health.

Company: ENABLE BIOSCIENCES
Inspection Date: October 17, 2024
Product Type: Medical Devices & Rad Health
Office: San Francisco District Office
Person: Nga T. Ho (Investigator)

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ID · 14923e0a-48b4-44f8-bcb7-29acd428842a

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1251998
FDA center: Medical Devices & Rad Health
Project area: Compliance: Medical Devices
Outcome: Form 483 issued, view the record

FDA Citations

21 CFR 820.198(a)Lack of or inadequate complaint procedures

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FDA Inspection

ENABLE BIOSCIENCESOctober 17, 2024