483
DLC Laboratories, IncFDA 483 - DLC Laboratories, Inc - January 31, 2025
Record Details
DLC Laboratories, Inc. in Paramount, CA, was inspected by the FDA from January 27-31, 2025, and received a Form 483. The inspection revealed a significant deficiency in the firm's quality system, specifically the failure to establish written procedures for production and process controls to address nitrosamine impurities in amine-containing drug products. This indicates a serious lapse in ensuring drug product quality and safety.
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ID · d519706d-4c3a-4828-8ef1-1ca89773ef47