483
Orange Lab HoldingsFDA 483 - Orange Lab Holdings - December 20, 2024
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An FDA inspection of Orange Lab Holdings in Anaheim, CA, revealed eight significant deficiencies in their manufacturing of OTC drug and cosmetic products. The firm demonstrated a pervasive lack of fundamental CGMP controls, including an absent quality control unit, unvalidated processes, and inadequate data integrity measures. Several critical issues were repeat observations from a previous inspection, highlighting persistent non-compliance.
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ID · c45733e1-d98a-4cf4-9a5c-d25c9207d613