Drugs

Multiple Violations at Cosmaceutical Research

An 11/18-11/22/19 FDA inspection at Cosmaceutical Research Lab, Surrey, BC, Canada, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and other violations. A 5/29 Warning Letter says the firm also manufactures two over-the-counter drug products, one of which is an unapproved new drug. The letter says specific CGMP violations were:

failing to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards;
failing to establish laboratory controls including scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity;
failing to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products; and
failing to thoroughly investigate any unexplained discrepancy or failure of a batch of any of its components to meet any of its specifications, whether or not the batch has already been distributed.

The letter also lists unapproved and misbranding violations for the firm’s Dr. Numb Lidocaine Cream 4% - Topical Anesthetic.

FDA recommends that the firm engage a qualified consultant to assist it in meeting CGMP requirements. It also recommends that a consultant assist the firm with data integrity remediation. Cosmaceutical was told to submit (1) a comprehensive investigation into the extent of data record and reporting inaccuracies; (2) a current risk assessment of the potential effects of the observed failures on the quality of the firm’s drugs, and (3) a management strategy for the company that includes details of a global corrective and preventive action plan.

Cosmaceutical was told to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completion.

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