FDA Inspection

Saehan CorporationFebruary 16, 2023

FDA Inspection 1197552 - Saehan Corporation - February 16, 2023

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Record Details

This FDA Inspection record concerns Saehan Corporation, with an inspection on February 16, 2023, issued by the Center for Devices and Radiological Health, covering devices.

Company: Saehan Corporation
Inspection Date: February 16, 2023
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Alexandria L. Capuano (Investigator)

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ID · c049ecfa-e048-46c5-89d2-ae1221aabd77

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1197552
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures

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