FDA 483 - Custom Research Labs Inc - June 04, 2021

Custom Research Labs Inc, a drug manufacturer in Gardena, CA, was inspected by the FDA from June 1-4, 2021. The inspection revealed significant deficiencies across multiple quality systems, including inadequate quality control unit procedures, lack of investigations into discrepancies, incomplete production records, and insufficient stability data for drug products. Several observations, such as inadequate annual product reviews, lack of process validation, and absence of stability data, were repeats from a 2016 FDA inspection, indicating persistent non-compliance with GMP regulations.