Oberg Medical - Finishing SolutionsJuly 9, 2019

FDA 483 - Oberg Medical - Finishing Solutions - July 09, 2019

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An FDA inspection of Broad Peak Manufacturing, LLC, a medical device contract manufacturer in Wallingford, CT, identified a significant issue with document control procedures. The firm failed to obtain required customer approval for changes to prosthetic knee implant production processes and shipped devices before necessary approvals were secured, indicating a breakdown in their quality system.

Company: Oberg Medical - Finishing Solutions
Inspection Date: July 9, 2019
Product Type: Device
Office: Division of Northeast Imports
Person: Jeffrey J. Thibodeau (Power Trader/Data Scientist)

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ID · 22747981-f53a-48a9-a51b-3e1ec9e672d1