FDA 483 - RLC Labs Inc. - September 15, 2023

Specialty Process Labs LLC in Phoenix, AZ, an Active Pharmaceutical Ingredient (API) manufacturer, received a Form 483 citing three significant observations. The firm failed to ensure the timely destruction of recalled drug products, lacked documented procedures for laboratory data control and sample chain-of-custody, and did not have an adequate ongoing stability testing program for its intermediates and APIs. These issues highlight serious deficiencies in quality control and data integrity.