Berchtold GmbH & Co. KG – FDA Inspection, May 18, 2017

Record Details

This FDA Inspection record concerns Berchtold GmbH & Co. KG, with an inspection on May 18, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: Berchtold GmbH & Co. KG
Inspection Date: May 18, 2017
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Claudette D. Brooks (FDA Associated Person)

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ID · fced78b6-c809-4091-bd45-e60e8a81f8e6

Inspection Facts

Inspection number: 1024848
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.100(b)Documentation
21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
21 CFR 820.50(a)(2)Supplier oversight

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FDA Inspection

Berchtold GmbH & Co. KGMay 18, 2017