483
Noble Pharma, LLCNoble Pharma, LLC – FDA 483, Mar 6, 2025
Record Details
Noble Pharma LLC, a drug manufacturer in Menomonie, WI, was cited with three observations during an FDA inspection. The firm failed to adequately validate equipment and processes for drug manufacturing, lacked proper facility configuration to prevent contamination, and had deficient controls over computer systems, including the use of a default log-on. These issues indicate significant concerns regarding GMP compliance and data integrity.
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ID · c04e1180-5007-41e7-b4e4-bfa5b00c9d91
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