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# CGMP Issues at Mylan Sangareddy Plant
- URL: https://www.fdaweb.com/cgmp-issues-at-mylan-sangareddy-plant/
- Published: 2020-09-01T12:00:00.000Z
- Updated: 2026-09-14T16:27:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147555

A 2/24-2/28 FDA inspection at the Mylan drug manufacturing facility in Sangareddy District, India, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). An 8/20 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mylan-laboratories-limited-unit-7-607508-08202020?ref=fdaweb.com) says specific deviations were: 

- failing to have adequate cleaning procedures to prevent contamination or carry-over of a material that would alter the quality of the API; and
- failing to control and monitor procedures to recover solvents to ensure that they meet appropriate standards before reuse.

The letter says the agency cited similar deviations at another facility in the company’s network in 2019\. “These repeated failures at multiple sites manufacturing API demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate,” the letter says. “You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems and processes and, ultimately, the products manufactured conform to FDA requirements at all your sites.”

Mylan was told to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completing the actions.