What made the US FDA issue a warning letter to Sun Pharma’s subsidiary Caraco?
The US FDA had issued a warning letter to Sun Pharma’s subsidiary Caraco Pharmaceutical Laboratories on Oct 31, 2008. The letter is now available on the FDA site detailing the reasons why the warning was issued. It points out deviations from current Good Manufacturing Practice (CGMP) regulations for medicines. These deviations were detected in an inspection between May 1 to June 11 2008, and are mainly due to issues related to quality control.
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