483
Molecular Therapeutics LLCMolecular Therapeutics LLC – FDA 483, Sep 10, 2025
Record Details
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.
- Office
- Atlanta District Office
- Person
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ID · 600127b5-4dea-4b2d-b6c1-60820b4f6945
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