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

Source: https://www.keypedia.com/records/483/oberg-medical-finishing-solutions/22747981-f53a-48a9-a51b-3e1ec9e672d1

> FDA 483 for Oberg Medical - Finishing Solutions on July 09, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Oberg Medical - Finishing Solutions
- Inspection Date: 2019-07-09
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: 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.

## Related Officers

- [Power Trader/Data Scientist](https://www.keypedia.com/people/jeffrey-j-thibodeau/62b74030-4aef-400b-8ae2-8bf84712d813)

Company: https://www.keypedia.com/companies/oberg-medical-finishing-solutions/2ce90db5-ef61-4a93-b8af-45c5fbbeee1b

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94