# FDA 483 - BALT USA, LLC - March 12, 2020

Source: https://www.keypedia.com/records/483/balt-usa-llc/e2d3fc62-759c-4012-82cd-6727249af8fe

> FDA 483 for BALT USA, LLC on March 12, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BALT USA, LLC
- Inspection Date: 2020-03-12
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of BARD USA, LLC, a medical device manufacturer in Irvine, CA, revealed a significant issue with their quality system. The firm failed to adequately establish procedures for controlling nonconforming products, specifically regarding the lack of root cause investigations for a substantial number of nonconformance reports. This indicates a moderate severity issue related to quality control and adherence to internal procedures.

## Related Documents

- [483 - 2023-07-21](https://www.keypedia.com/records/483/balt-usa-llc/e8bb7f4e-a123-4683-9163-25d5fd3424c3)

## Related Officers

- [Matthew D. Schnittker](https://www.keypedia.com/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.keypedia.com/companies/balt-usa-llc/6783eb4f-96f7-4c7c-80d9-4447fdb185cc

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6