Drugs

CGMP Violations at K.C. Pharmaceuticals

A 1/18-1/27 and 2/10-2/13 FDA inspection at K.C. Pharmaceuticals in Pomona, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 8/3 Warning Letter says specific violations were:

failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
failing to perform operations within specifically defined areas of adequate size and having separate or defined areas or other such control systems necessary to prevent contamination or mix-ups in aseptic processing areas; and
failing to establish and follow adequate written procedures for cleaning and maintaining equipment.

FDA says significant findings in the letter demonstrate that the company does not operate an effective quality system following CGMP. “In addition to the lack of effective production operations oversight to ensure reliable facilities and equipment, we found your quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities,” the agency says.

The letter strongly recommends that K.C. engage a qualified consultant to assist it in meeting CGMP requirements.

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

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome