Cellex-C International Inc. – FDA Warning Letter, Jan 19, 2017

The FDA inspected Cellex-C International Inc.'s drug manufacturing facility in Toronto from January 16-19, 2017, identifying significant violations of current Good Manufacturing Practice (CGMP) regulations (21 CFR parts 210 and 211), rendering their drug products adulterated under section 501(a)(2)(B) of the FD&C Act. The firm's February 7, 2017, response was deemed inadequate due to insufficient detail and a lack of comprehensive action plans.

Key deficiencies included the failure to test finished drug products for active ingredient identity and strength prior to release (21 CFR 211.165(a)), and the failure to test incoming components for identity, purity, strength, and quality (21 CFR 211.84(d)(1), (2)), with an unacceptable reliance on supplier Certificates of Analysis. The firm also lacked established written responsibilities and procedures for its quality control unit (21 CFR 211.22(d)), adequate written procedures for production and process control, including process validation (21 CFR 211.100(a)), and complete batch production and control records (21 CFR 211.188).

FDA strongly recommended engaging a qualified CGMP consultant. As a result of these violations, the firm was placed on Import Alert 66-40 on June 2, 2017. Failure to correct these issues may lead to continued refusal of product admission into the U.S. and withholding of new drug application approvals. The firm must respond within 15 working days with detailed corrective actions and timelines.