# FDA 483 - BALT USA, LLC - July 21, 2023

Source: https://www.keypedia.com/records/483/balt-usa-llc/e8bb7f4e-a123-4683-9163-25d5fd3424c3

> FDA 483 for BALT USA, LLC on July 21, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BALT USA, LLC
- Inspection Date: 2023-07-21
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of BALT USA, LLC in Irvine, CA, a manufacturer of Class II medical devices, revealed significant deficiencies in its quality system. The firm failed to timely report medical device malfunctions that could lead to serious injury or death, and also lacked proper documentation for corrective and preventive actions. Additionally, the acceptance status of subassembly lots was not adequately identified, indicating a systemic breakdown in quality control.

## Related Documents

- [483 - 2020-03-12](https://www.keypedia.com/records/483/balt-usa-llc/e2d3fc62-759c-4012-82cd-6727249af8fe)

## Related Officers

- [Marlo-Ian M. Alintanahin](https://www.keypedia.com/people/marlo-ian-m-alintanahin/a37da927-b369-4753-b275-41743556f25e)

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