Colonial Dames CGMP Violations

A 4/4-4/12/2023 FDA inspection at the Colonial Dames drug manufacturing facility in Commerce, CA, found repeat significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 12/5/2023 Warning Letter says specific drug adulteration violations were:

• failing to establish adequate written procedures for production and process control designed to assure that the drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess;
• failing to clean, maintain, sanitize, and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements, and failing to establish and follow adequate written procedures for cleaning and maintenance of equipment;
• failing to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and its cleaning and maintenance;
• failure of the firm’s quality control unit to exercise its responsibility to ensure drug products manufactured comply with current good manufacturing practices and meet established specifications for identity, strength, quality, and purity; and
• failing to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use the results of stability testing to determine appropriate storage conditions and expiration dates.

The letter also lists unapproved new drug and misbranding violations and concerns raised by the Center for Food Safety and Applied Nutrition.

FDA notes that similar CGMP violations were identified in 2015 and 2021 inspections and that a regulatory meeting was held with the company on 11/10/2021 to discuss the inspection observations. “You proposed specific remediations for these observations in your response,” it says. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.”

The letter recommends that Colonial Dames engage a qualified consultant to perform a comprehensive six-system (i.e., Quality System, Facilities & Equipment System, Materials System, Production System, Packaging & Labeling System, and Laboratory Control System) audit of its entire operation for CGMP compliance, assist it in meeting CGMP requirements, and evaluate the completion and efficacy of all corrective and preventive actions before the firm pursues resolution of its compliance status with FDA.

Colonial Dames was told to correct the violations promptly and respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.