# FDA 483 - OSI Batteries, LLC - October 28, 2024

Source: https://www.globalkeysolutions.net/records/483/osi-batteries-llc/b607ed6a-996a-4ea7-84dd-97d6c79775c4

> FDA 483 for OSI Batteries, LLC on October 28, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OSI Batteries, LLC
- Inspection Date: 2024-10-28
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: OSI Batteries, LLC, a contract manufacturer of medical device battery packs in Minnetonka, MN, was cited for significant deficiencies in its quality system. The inspection revealed inadequate process control procedures for battery maintenance, production changes, and manufacturing transfers. Additionally, the firm failed to perform required internal quality audits.

## Related Officers

- [Albert L. Nguyen](https://www.globalkeysolutions.net/people/albert-l-nguyen/496338d0-71c4-43da-92f0-09515559d9fc)

Company: https://www.globalkeysolutions.net/companies/osi-batteries-llc/13c08fbe-e121-410b-b3e8-83b45b529f46

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d