FDA 483 - Ex-Lax, Inc. - March 31, 2017

An FDA inspection of Ex-Lax, Inc. in Humacao, PR, a manufacturer of pharmaceutical and animal drug products, revealed significant deficiencies in their manufacturing and quality control systems. Observations included inadequate process validation for animal drug products, incomplete batch records, and poorly documented investigations into quality events and deviations. Additionally, the firm failed to properly calibrate and maintain laboratory instruments and lacked sufficient detail in cleaning and maintenance procedures.