Drugs

Strukmyer Medical CGMP Violations

A 7/8-8/1/2024 FDA inspection at the Strukmyer Medical drug manufacturing facility in Mesquite, TX, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 1/30 Warning Letter says specific violations were:

failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality, and failure to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals;
failure 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 a drug product beyond the official or other established requirements; and
failure to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, in-process materials, packaging materials, labeling, and drug products.

FDA recommends that Strukmyer retain a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements.

The letter notes that some of the firm’s products may be regulated as cosmetics and says that some conditions that caused its drug products to be adulterated may also cause its cosmetic products to be adulterated.

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

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