Oberg Medical - Finishing Solutions – FDA Inspection, Jul 9, 2019

Record Details

This FDA Inspection record concerns Oberg Medical - Finishing Solutions, with an inspection on July 9, 2019, issued by the Center for Devices and Radiological Health, covering devices.

Company: Oberg Medical - Finishing Solutions
Inspection Date: July 9, 2019
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Jeffrey J. Thibodeau (FDA Associated Person)

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ID · ed586f65-e8a9-4189-85d9-a347c5b148c9

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1096802
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.40Procedures not adequately established or maintained

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FDA Inspection

Oberg Medical - Finishing SolutionsJuly 9, 2019