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 purity they are represented to possess, said media reports.
The 10-page Form 483 to Sun Pharma, which is issued to companies as an observation by investigators over deemed violation of US drug regulations upon completion of an inspection, also observed that the latter's Dadra plant's quality control unit lacked authority to fully investigate errors that have occurred. In other words, the quality control unit at the Dadra facility did not always ensure complete investigation of errors that may have occurred at the plant.
USFDA's 483 to Sun Pharma reportedly also includes observation regarding its laboratory records which do not include complete data derived from all tests and examinations. The regulator's observed that these data were imperative to assure compliance with established specifications and standards. Further, the regulator also did not find the Dadra facility's electronic records meeting requirements that would ensure trustworthiness and reliability.
When asked about the observations, a Sun Pharma spokesperson stated, "We have submitted our response to the US FDA. Sun Pharma intends to implement promptly any corrective actions and improvements that may be necessary and remains committed to following the highest levels of quality and 24x7 cGMP compliance at all its manufacturing sites globally."