Keranetics Inc. – FDA Inspection, Feb 6, 2025

Record Details

This FDA Inspection record concerns Keranetics Inc., with an inspection on February 6, 2025, issued by the Atlanta District Office, covering medical devices & rad health.

Company: Keranetics Inc.
Inspection Date: February 6, 2025
Product Type: Medical Devices & Rad Health
Office: Atlanta District Office
Person: Christopher B. May (Investigator)

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ID · 09ddbf6d-7968-4b36-b069-878e44fb2c57

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1260145
FDA center: Medical Devices & Rad Health
Project area: Compliance: Medical Devices
Outcome: Form 483 issued, view the record

FDA Citations

21 CFR 820.20(c)Management review - defined interval, sufficient frequency
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.22Quality Audit/Reaudit - conducted
21 CFR 803.17Lack of Written MDR Procedures

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FDA Inspection

Keranetics Inc.February 6, 2025