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Cipla has received observations for its Goa unit, from the US health regulator.
The USFDA conducted a product specific pre-approval inspection, at Goa plant in January 2018. As per Cipla, the company received few observations which are procedural in nature and the company also stated that they have responded to the agency on all the observations.
The observations received are: failure to thoroughly review batch if it’s already been distributed, batch production and control records are deficient, laboratory records are deficient; records don’t include complete testing data, established test procedures are not followed, reserve samples not examined visually at least once a year for evidence of deterioration, testing and release of drug product don’t include appropriate lab determination, responsibilities and procedures w.r.t quality control unit not in writing & fully followed and equipment used in manufacturing, processing, packing is not of appropriate design.
