# FDA 483 - Trix Manufacturing, Inc. - May 23, 2002

Source: https://www.keypedia.com/records/483/trix-manufacturing-inc/5accf3a8-b3c1-4e64-ade9-f905edc1c805

> FDA 483 for Trix Manufacturing, Inc. on May 23, 2002. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Trix Manufacturing, Inc.
- Inspection Date: 2002-05-23
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Trix Manufacturing, Inc. in Jacksonville, SC, a drug manufacturer, was cited for multiple deficiencies during an FDA inspection. The observations primarily focused on the firm's failure to ensure the authenticity, integrity, and security of electronic records and the lack of validation for computer systems. Additionally, the firm lacked proper audit trails and written procedures for product distribution and release criteria.

## Related Officers

- [Henry H. McCarver](https://www.keypedia.com/people/henry-h-mccarver/6001f960-3f89-4436-b0b6-9d401dc66cdc)

Company: https://www.keypedia.com/companies/trix-manufacturing-inc/25c62628-5ca3-4298-94d0-8328d503e385

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7