USFDA issues warning letter to Intas over 'quality lapses'

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.

Disclaimer : Mytimesnow (MTN) lets you explore worldwide viral news just by analyzing social media trends. Tap read more at source for full news. The inclusion of any links does not necessarily imply any endorsement of the views expressed within them.