FDA 483 - O.L. Products Inc. - August 14, 2019

G.S.L. Products Inc., an OTC repacker in Oldsmar, FL, was cited for significant deficiencies in its quality control unit, cleaning and maintenance procedures, and stability testing program. The inspection revealed a lack of written procedures for critical operations such as purchasing controls, deviation investigations, and change control. Additionally, the firm failed to establish a formal stability program to determine drug product expiry dates.