Drugs

Zydus/Cadila Gets FDA-483 After Inspection

FDA has issued Zydus Lifesciences (formerly known as Cadila Healthcare) a three-item Form FDA-483 after inspecting the firm’s Jarod, Gujarat (India) injectable facility between 2/24 and 3/10. Without disclosing the cited observations, the company says it is confident they will be addressed and corrected to the agency’s satisfaction.

Cadila has a recent history of FDA compliance concerns. Earlier this year Viona Pharmaceuticals recalled 33 lots of Cadila-manufactured metformin HCl extended-release tablets 750 mg due to an out-of-specification result observed for the product that detected N-nitrosodimethylamine. An agency notice says the product was manufactured by Cadila’s Ahmedabad, India facility for U.S. distribution by Viona.

In 2019, FDA issued a Warning Letter after an inspection cited significant GMP violations. Specificic issues cited included:

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;
failing 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 has already been distributed;
failing to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes;
failing to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

The letter also acknowledged a 10/2/2019 communication informing FDA that the company would permanently cease production of injectable drug products for the U.S. “It is important to note that full remediation of the related CGMP violations cited will be necessary if you decide to resume the manufacturing of injectable drug products at this site, or if any successor firm assumes responsibility over the site’s operation in the future,” it said.

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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