> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Inspection Hits Zydus With Form-483
- URL: https://www.fdaweb.com/fda-inspection-hits-zydus-with-form-483/
- Published: 2024-04-15T12:00:00.000Z
- Updated: 2026-09-14T14:28:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156779

FDA issued Zydus Lifesciences a four-item [Form FDA-483](https://www.fda.gov/media/177746/download?attachment&ref=fdaweb.com) after inspecting the firm’s manufacturing facility (Matoda, Gujarat, India). The form said Zydus’ aseptic processing areas are deficient, specifically its system for monitoring environmental conditions. For example, it said that from 5/23 to 12/2023 the firm manufactured and distributed human drug products intended to be sterile when its environmental monitoring program for viable microorganisms was not in a state of control.

Additionally, the inspection found that procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written and followed. And, FDA said, buildings used in the manufacturing, processing, packing and holding of drug prroducts are not maintained in a good state of repair. For example, the roof of the building that covers the aseptic filling line had multiple holes in it and the sky could be seen through the holes.

Zydus Lifesciences (formerly known as Cadila Healthcare) has been in FDA’s crosshairs over the past few years. In 2022, 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](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/viona-pharmaceuticals-inc-issues-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets-0?ref=fdaweb.com) says the product was manufactured by Cadila’s Ahmedabad, India facility for U.S. distribution by Viona.

In 2019, FDA issued a [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cadila-healthcare-limited-584856-10292019?ref=fdaweb.com)after an inspection cited significant GMP violations. Specific 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.