FDA 483 - PRIMA FLEUR Botanicals, Inc. - October 30, 2024
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An FDA inspection of PRIMA FLEUR BOTANICALS INC in Novato, CA, a manufacturer of drug products, revealed significant deficiencies in their quality control unit and overall adherence to current good manufacturing practices. The firm failed to establish written procedures for quality oversight, product testing, stability programs, process validation, and maintaining complete batch production records. Additionally, equipment used in manufacturing was not appropriately designed, qualified, or sanitized.
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