FDA Policy/General

Chem-Tech Inspection Violations

A 9/17-9/20/2024 FDA inspection at the Chem-Tech drug manufacturing facility in Pleasantville, IA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 2/11 Warning Letter says the 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 clean, maintain, and 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 failure to establish and follow adequate written procedures for cleaning and maintaining equipment; and
failure to establish and follow adequate written responsibilities and procedures applicable to the quality control unit.

The letter says Chem-Tech’s responses to the inspection observations were inadequate because it didn’t provide supportive documentation for evaluation or adequate evidence of corrective actions being taken to comply with CGMP.

FDA acknowledges the firm’s recall of a redacted drug due to CGMP violations cited after the inspection occurred and the company’s commitment to cease production of a redacted drug at the facility. Chem-Tech is to notify FDA if it plans to resume any drug manufacturing operations.

The agency recommends that the firm engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements if it intends to resume manufacturing drugs for the U.S. market.

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

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