Drugs

CGMP Issues at LEC Custom Products

David McFarland

— 2 min read
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A 3/2-3/6 FDA inspection at the LEC Custom Products drug manufacturing facility in Brampton, Ontario, Canada, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 9/24 Warning Letter says specific violations were: 

  •          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;
  •          failing to establish 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, and, as appropriate for the nature of the drug, 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;
  •          failing to establish a written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates;
  •          failing to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality and failing to validate and establish the reliability of component supplier test analyses at appropriate intervals; and
  •          failing to establish an adequate quality control unit and failing to have in writing and to fully follow responsibilities and procedures applicable to the quality control unit.

The letter says the company indicated it was ceasing drug manufacturing at the Brampton site and moving all of its drug production operations to its Mississauga site. “Based on repeat observations and your failure to follow through with written commitments to perform various corrective actions at the Brampton and Burlington sites, you do not have adequate executive management oversight and control over the manufacture of drugs,” FDA says.

The letter recommends that LEC engage a qualified consultant to evaluate its operation and assist it in meeting CGMP requirements. It also recommends that the consultant perform a comprehensive audit of the firm’s entire operation for CGMP compliance and evaluate the efficacy and completeness of corrective and preventive actions before LEC pursues resolution of its compliance status with FDA.

FDA placed LEC on import alert 7/14. The company was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completing the actions.

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