Drugs

Wisconsin Pharmacal CGMP Violations

A 3/3-3/7 FDA inspection at the Wisconsin Pharmacal drug manufacturing facility in Jackson, WI, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/22 Warning Letter says the specific violations were:

failure of the quality control unit to exercise its responsibility to ensure that manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity;
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 was already distributed; and
failure to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records.

The letter says the firm’s responses to the inspection observations were inadequate. FDA recommends that Wisconsin Pharmacal engage a qualified consultant to assist it in meeting CGMP requirements.

The company was told 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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