FDA Inspection
Audicon CorporationAudicon Corporation – FDA Inspection, Aug 8, 2025
Record Details
This FDA Inspection record concerns Audicon Corporation, with an inspection on August 8, 2025, issued by the Los Angeles District Office, covering medical devices & rad health.
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ID · e5742356-6f7f-4e21-aa9f-149594cc541d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1277981
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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