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USFDA issues warning letter to Intas over 'quality lapses'
![IndiaTimes]()
Monday, 4 December 2023
US FDA issues warning letter to Intas for violations at Ahmedabad facility, citing lapses in CGMP regulations. The letter highlights identity, strength, quality, and purity issues in the company's drugs. It mentions that Intas' QA and production departments failed to ensure data reliability. The USFDA also found that operators manipulated defect counts to keep rejections within limits. Intas responded to the charges in July, but the response was deemed inadequate.
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