Raising concerns over data collection and quality control unit, the US Food and Drug Administration (USFDA) has reportedly issued a Form 483 to Sun Pharmaceutical Industries Ltd for its Dadra plant.
As per media reports, the regulator is learnt to have found deficiencies relating to medicine quality, data collection, maintenance as well as quality control unit. After an inspection of Sun Pharma's Dadra plant in March this year, USFDA has reportedly issued 11 observations on the site.
The observations include lack of written procedures for production and process controls designed to assure that drug products have identity, strength, quality, and