# FDA 483 - Molecular Therapeutics LLC - September 10, 2025

Source: https://www.globalkeysolutions.net/records/483/molecular-therapeutics-llc/600127b5-4dea-4b2d-b6c1-60820b4f6945

> FDA 483 for Molecular Therapeutics LLC on September 10, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Molecular Therapeutics LLC
- Inspection Date: 2025-09-10
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Molecular Therapeutics LLC in Athens, GA, a manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, quality audits, and management review. These observations indicate a fundamental lack of documented processes essential for maintaining product quality and regulatory compliance.

## Related Officers

- [Dawn M. Braswell](https://www.globalkeysolutions.net/people/dawn-m-braswell/6a66fdbb-fff8-4b4b-9f06-320464957b87)

Company: https://www.globalkeysolutions.net/companies/molecular-therapeutics-llc/a79f527e-ac16-46f1-ad70-f62018357b8b

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