Canadian OTC Drugmaker Warned for GMP Failures

The FDA has issued a warning letter to LEC Custom Products, an over-the-counter (OTC) drug manufacturing facility in Ontario, Canada, for serious violations of current good manufacturing practices.

FDA investigators found that equipment at the LEC Custom Products facility used in the manufacture of OTC products did not meet standards for cleaning and maintenance.

The agency also cited the company for failing to validate its manufacturing process to ensure the identity, strength, quality and purity of the OTC products. The investigators found inadequate cleaning and sterilization of shared equipment used for manufacturing multiple products.

In addition, the firm lacked a stability testing program and failed to periodically verify testing by its component supplier.