483
Western Chemical Inc.FDA 483 - Western Chemical Inc. - December 23, 2019
Record Details
Syndel USA in Ferndale, WA, a drug manufacturer, was cited for significant deficiencies in its quality control unit and laboratory operations during an FDA inspection. Observations included failures to follow recall and corrective action procedures for a sub-potent product, inadequate laboratory controls with unqualified personnel verifying test results, and a lack of documented review for HPLC software audit trails to ensure data integrity. These issues indicate a systemic breakdown in ensuring product quality and data reliability.
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ID · 88a669a2-e8f8-48ab-8762-b7fe25f36257