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# Wintac Warned on CGMP Inspection Violations
- URL: https://www.fdaweb.com/wintac-warned-on-cgmp-inspection-violations/
- Published: 2020-08-25T12:00:00.000Z
- Updated: 2026-09-14T16:26:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147506

A 2/10-2/19 FDA inspection at a Wintac Limited drug manufacturing facility in Bangalore, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. An 8/13 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wintac-limited-606700-08132020?ref=fdaweb.com) says specific violations were: 

- failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether the batch had already been distributed; and
- failing to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes.

FDA recommends the firm engage a qualified consultant to assist it in meeting CGMP requirements. Wintac was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completing the actions.