FDA 483 - Neutraderm Inc. - June 15, 2026
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Neutraderm, Inc. in Chatsworth, CA, a drug manufacturer, was cited for significant deficiencies across its quality system and laboratory controls. The inspection revealed inadequate investigations into out-of-specification results, customer complaints, and defective materials, alongside issues with equipment qualification and cleaning logs. Further observations included a lack of proper contamination testing, incomplete annual product reviews, outdated cleaning validation, and failures in issuing authentic Certificates of Analysis for repacked APIs.
ID · c85d6da4-f8d5-4308-b0fd-302a1daecbff