Drugs

CGMP Issues at India’s Kenil Healthcare

A 12/5-12/11/2024 FDA inspection at the Kenil Healthcare Private Limited drug manufacturing facility in Gujarat, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 6/12 Warning Letter says the specific violations were:

failure 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;
failure to have buildings used in the manufacture, processing, packing, or holding of drug products with adequate space for the orderly placement of equipment and materials to prevent mix-ups and contamination; and
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.

FDA acknowledges that the company is using an independent third-party consultant to audit its operation and assist it in meeting FDA requirements. It also acknowledges the company’s action in recalling all drugs within expiry currently in distribution in the U.S. as recommended by FDA. All of the firm’s drugs were placed on a 4/4 Import Alert.

Kenil was told to correct the violations promptly and to respond with a list of specific steps it has taken to address the 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