# FDA 483 - BIT Group USA, Inc. - December 11, 2019

Source: https://www.keypedia.com/records/483/bit-group-usa-inc/c504fc2b-d167-4d1a-8cdf-248fd39eda33

> FDA 483 for BIT Group USA, Inc. on December 11, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BIT Group USA, Inc.
- Inspection Date: 2019-12-11
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of BIT Group USA, Inc., a contract manufacturer in San Diego, CA, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for controlling non-conforming product, specifically lacking requirements for investigation evaluations. Additionally, procedures for corrective and preventive actions were found to be inadequate, with a specific CAPA record missing a documented investigation into the root cause of a non-conformance.

## Related Officers

- [investigator](https://www.keypedia.com/people/matthew-m-vernon/f77e8c18-8614-49e3-9b19-3327b7fe7648)

Company: https://www.keypedia.com/companies/bit-group-usa-inc/af1009da-cf69-4c69-b8cb-0523e72842c6

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