FDA 483 - Private Label Select Ltd. Co. - July 23, 2021

Private Label Select Ltd. Co., an OTC drug manufacturer in Taos, NM, was cited for numerous deficiencies during an FDA inspection. The firm failed to validate manufacturing processes, investigate out-of-specification results, and conduct adequate stability studies for its drug products. Significant issues were also noted in laboratory controls, equipment design and cleaning, complaint handling, and quality unit oversight, indicating a systemic lack of adherence to GMPs.