Zydus Lifesciences, an Indian manufacturer of sirolimus that many in the community rely on, recently received a warning letter from the FDA on August 29, 2024. This letter outlines significant violations of Current Good Manufacturing Practices (CGMP) at their facility in Gujarat, India. Key concerns include cross-contamination during drug production, inadequate cleaning procedures, and failures to prevent microbiological contamination in sterile products. The FDA’s findings also revealed instances of glass particulate contamination in certain drug batches.
The company has initiated recalls for affected products, which does not include sirolimus. However, the FDA deemed Zydus’ response inadequate in addressing the root causes and implementing corrective actions. Until these issues are fully resolved, Zydus may face restrictions on importing their products into the U.S.
Here’s a link to the FDA warning letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-685224-08292024