The US Food and Drug Administration (US FDA) has found several deficiencies, including those relating to medicine quality as well as data collection and maintenance, during a recent inspection of one of Sun Pharmaceutical Industries Ltd’s largest drug making units in India. The regulator, which inspected the drug giant’s unit in Dadra late in March, has issued 11 observations on the site.
“There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess,” US FDA investigators observed in their 10-page Form 483 to Sun Pharma, a copy of which The Indian Express has reviewed. An FDA Form 483 is issued to companies upon completion of an inspection when investigators observe conditions deemed to violate US drug regulations. In the Form 483 to Sun Pharma, investigators further observed that the Dadra facility’s quality control unit “lacks authority to fully investigate errors that have occurred.” Explaining this observation, the investigators added that, specifically, the quality unit does not always ensure errors are fully investigated.
Another observation by investigators was that laboratory records “do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.” They add that electronic records are used, but they “do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.” Out of the 11 observations made, these three are “serious” in nature, according to Ranjit Barshikar, a quality expert consultant to the United Nations. If left unresolved, they could lead to US FDA issuing a warning letter, he said.
“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 24×7 cGMP compliance at all its manufacturing sites globally,” Sun Pharma’s spokesperson told The Indian Express.
“These observations are serious because they affect the quality of the product going into the market,” Barshikar told The Indian Express. “Anything that is going to impact patients and the stability of the products is always an observation of serious nature and has scope for US FDA to issue warning letters if the issues are not resolved,” he added. “The quality control unit must have all evidential documents that confirm that there is no manipulation of the data. Here, the language used by the inspectors implies that the data is not trustworthy,” said Barshikar, referring to US FDA’s observation on laboratory records. On US FDA’s observations pertaining to drug quality and investigation of errors, Barshikar said that, if the quality assurance department of a manufacturing unit is not properly monitoring the production, it could lead to batches of medicines being released in the market without being properly tested. If the quality control department is not well-equipped, or does not have the knowledge, to conduct investigations into errors, it could lead to a “serious problem” of batches continuously failing quality tests, he added.
“This may affect the patient’s health and safety,” he said. “There are so many warning letters to this point in past to many good companies.”