Sun Pharma gets 11 USFDA observations for Dadra plant, BSE asks for response: Report

New Delhi: Sun Pharmaceutical (Sun Pharma) Industries Ltd's Dadra plant has reportedly received 11 observations, "serious" in nature from the U.S. Health regulator complying deficiencies pertinent to the quality control unit, data collection and maintenance. According to a recent media report, the regulators have conducted an inspection of the firm's largest drug-making unit in Dadra a month ago.

As per a report in The Indian Express, USFDA has issued 10 pages Form 483 to Sun Pharma. Form 483 is issued to companies as an observation by investigators over deemed violation of the US drug regulations upon completion of an inspection.

Sun Pharma has received USFDA observations including;

• No written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.


• Dadra facility's quality control unit "lacks authority to fully investigate errors that have occurred."


• Laboratory records "do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards."


• It is also learnt that electronic records are used, but they "do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records."

Ranjit Barshikar, a quality expert consultant to the United Nations told the daily that out of the 11 observations made, the above-mentioned ones are "serious" in nature and if left unresolved, they could lead to US FDA issuing a warning letter.

When asked about the observations, a Sun Pharma spokesperson told The Indian Express, "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."

Following media reports, the stock exchange has sought clarification from Sun Pharma with respect to the issues reported.

The Exchange has sought clarification from Sun Pharmaceutical Industries Ltd with respect to news article appearing on www.indianexpress.com April 25, 2019, titled "US FDA finds quality, data issues at Dadra plant of Sun Pharma".The reply is awaited. said the BSE filing

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