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Key Takeaway: Glutathione is a vital molecule produced by the body that defends cells from damage and plays a direct role in regulating skin pigmentation

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10.1124/jpet.107.128009 330 WorthleyM

Inadequate Remediation Scope: The firm proposed to perform audit trail reviews for "active ingredient assays." The FDA deemed this inadequate because it excluded "other electronic laboratory data associated with component and finished-product testing".8 The requirement for data integrity applies to all CGMP data, including excipient testing, in-process checks, and stability data