# FDA 483 - Willow Birch Pharma, Inc. - May 03, 2024

Source: https://www.globalkeysolutions.net/records/483/willow-birch-pharma-inc/738a0558-21ee-4b12-ae88-67aec0d79fd6

> FDA 483 for Willow Birch Pharma, Inc. on May 03, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Willow Birch Pharma, Inc.
- Inspection Date: 2024-05-03
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: Willow Birch Pharma, Inc. in Taylor, MS, an API repackager/relabeler, was cited for a significant lack of control over computer systems and related records during an FDA inspection. The firm failed to implement appropriate access controls and audit trails for electronic software used to generate labels and for word documents used to create certificates of analysis for repackaged active pharmaceutical ingredients. This indicates a serious deficiency in data integrity and record management practices.

## Related Officers

- [ CSO](https://www.globalkeysolutions.net/people/megan-t-ziegler/3e83a317-701a-4e40-bb43-34d294d3448f)
- [Investigator](https://www.globalkeysolutions.net/people/demario-l-walls/c69c4c87-f001-45ab-8d7b-b45c60226ff1)

Company: https://www.globalkeysolutions.net/companies/willow-birch-pharma-inc/a2496c28-dd6d-42f2-b524-6f6b8c20dbb8

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea