483
Medical Chemical CorporationFDA 483 - Medical Chemical Corporation - February 18, 2025
Record Details
Medical Chemical Corporation in Torrance, CA, a drug manufacturer, received an FDA Form 483 with eight observations highlighting significant deficiencies across its quality systems. Key issues include inadequate component identity and quality testing, lack of process and water system validation, incomplete batch production records, and insufficient investigations into out-of-specification results, all indicating a failure to assure drug product quality.
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ID · 753901f6-35e4-4211-b0b2-84be2cbf10a2