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Cites failure to ensure drug products manufactured at Gujarat, India plant comply with cGMP.
December 1, 2023
By: Kristin Brooks
Managing Editor, Contract Pharma
Intas Pharmacuticals has received another warning letter from the U.S. FDA regarding its plant in Gujarat, India. The warning letter posted November 28 names four issues found at the plant following a 12-day site inspection in May 2023. According to the FDA, the company failed to ensure drug products manufactured at the site comply with current Good Manufacturing Practice (cGMP) regulations. The letter cites manufacturing violations, quality control issues, and compromised data integrity. Th...
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