Drugs

API Deviations Found at Jost Chemical

A 1/10-1/21 FDA inspection at the Jost Chemical drug manufacturing facility in St. Louis, MO, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 7/18 Warning Letter says specific deviations were:

failure of the quality unit to ensure that quality-related complaints are investigated and resolved, and failure to extend investigations to other batches that may have been associated with a specific failure or deviations;
failure to establish adequate written procedures for cleaning equipment and its release for use in manufacturing APIs;
failure to ensure that all test procedures are scientifically sound and appropriate to ensure that the APIs conform to established standards of quality and purity, and failure to ensure laboratory data are complete and attributable; and
failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failure to establish and follow written procedures for the operation and maintenance of computerized systems.

The firm’s responses to the inspection observations were inadequate, FDA says. The letter says Jost’s quality system “does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture.” The agency recommends that the firm engage a qualified consultant to assist in its remediation.

The letter also raises concerns about the water system used to clean manufacturing equipment that produces sterile drug products and recommends that Jost engage a qualified consultant to assist it in meeting CGMP requirements.

The firm was told to respond with a list of specific actions it has taken to address the deviations and prevent their recurrence, with a schedule for completing the corrections.

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