# FDA 483 - Quality Tech Services, LLC - June 17, 2025

Source: https://www.globalkeysolutions.net/records/483/quality-tech-services-llc/50d8d4f7-84b9-4385-946a-e48e0fbd8a1d

> FDA 483 for Quality Tech Services, LLC on June 17, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Quality Tech Services, LLC
- Inspection Date: 2025-06-17
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Quality Tech Services, LLC, a contract manufacturer in Bloomington, MN, received a Form 483 citing two observations. The inspection revealed significant deficiencies in the firm's corrective and preventive action (CAPA) procedures, including inadequate investigations and failure to identify recurring quality problems. Additionally, the firm's procedures for preventing contamination of medical devices in cleanrooms were found to be inadequately established and inconsistent.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/quality-tech-services-llc/34829aa0-5f32-4393-9870-813401540664

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