Drugs

Calvin Scott & Company CGMP Violations

A 3/9-3/12 FDA inspection at the Calvin Scott and Company drug manufacturing facility in Albuquerque, NM, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. An 8/25 Warning Letter says specific violations were:

failing to assure that the drug product bore an expiration date that was supported by appropriate stability testing;
failing to establish and follow adequate written procedures for cleaning and maintenance of equipment; and
failing to establish a quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products.

FDA says that, based on the nature of the violations, it strongly recommends that the firm engage a qualified consultant to assist it in meeting CGMP requirements.

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 schedule for completing the actions.

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