Not long after receiving a Form 483 warning from the US regulator in relation to its Bollaram, India-based site, Dr Reddy’s said another Active Pharmaceuticals Ingredients (API) plant is set for a reinspection, this time at Srikakulam in Andhra Pradesh.
The US agency warned of a failure to fully investigate complaints from customers regarding out of spec APIs, as well as microbiological failures.
The company had already received a warning letter in 2015 relating to deviations from Current Good Manufacturing Practice (cGMP) at the facility, as well as at other sites in India.
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