Drugs

2 CGMP Violations in Natco Pharma Inspection

A 10/9-10/18/2023 FDA inspection at the Natco Pharma drug manufacturing facility in Telangana, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/8 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
failing to thoroughly investigate any 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.

FDA says the firm’s responses to the inspection observations were inadequate. The letter acknowledges the company’s commitment to temporarily suspend drug production for the U.S. market while the CGMP violations are remediated.

Natco was told to correct the violations promptly and 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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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