Drugs

CGMP Violations at Mexico’s Eksa Mills

A 4/18-4/19 FDA inspection at the Eksa Mills drug manufacturing facility in Zaragoza, Puebla, Mexico, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 10/5 Warning Letter says specific violations were:

failing to clean, maintain, and, as appropriate for the nature of the drug, 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 of the firm’s quality control unit to exercise its responsibility to ensure drug products manufactured comply with CGMP and meet established specifications for identity, strength, quality, and purity.

The letter acknowledges Eksa’s commitment to cease the production of drugs at the facility and that it deregistered the facility as a drug manufacturer. It tells the company to contact FDA in advance if it decides to resume drug production for the U.S. market.

FDA recommends that Eksa engage a qualified consultant to assist it in meeting CGMP requirements if it intends to resume manufacturing drugs for the U.S. market.

Eksa Mills was placed on an import alert on 8/12.

The firm was told to correct any 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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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome