Drugs

CGMP Violations in Spartan Chemical Inspection

A 3/1-3/26/21 FDA inspection at Spartan Chemical Company, Maumee, OH, found significant violations of current good manufacturing practice (CGMP) regulations. A 12/15/21 Warning Letter says specific violations were:

failing to establish adequate 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, and the firm’s quality control unit does not review and approve the procedures, including any changes;
failing 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; and
the firm’s quality control unit failed to exercise its responsibility to ensure that drug products manufactured comply with CGMP and meet established specifications for identity, strength, quality, and purity.

The letter also lists unapproved new drug and misbranding violations found during the inspection. The agency says the firm’s Web site indicates its consumer and healthcare antiseptic products are intended to mitigate, prevent, treat, or diagnose Covid-19 in people and the products’ labeling includes statements that falsely indicate that they are registered and approved by FDA.

Spartan’s response to the inspection observations was inadequate, the letter says.

FDA says the violations “demonstrate a failure of your executive management to exercise proper oversight and control over the manufacture of drugs. You should immediately and comprehensively assess your company’s manufacturing operations to ensure that systems, processes, and, ultimately, products conform to FDA requirements.”

FDA acknowledges the company’s commitment to temporarily suspend drug production at the facility and recommends that it retain a qualified consultant to assist it in meeting CGMP requirements.

Spartan was told to respond with a list of specific actions it has taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completing the corrections.

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