NSECNBC-TV18 has managed to access the warning letter issued by the United States Food and Drug Administration (USFDA) to Sun Pharmaceuticals Ltd.'s Dadra facility.
The observations range from failed to clean and maintain and sanitise equipment along with other repeat observations.
Sun Pharma's Dadra facility was issued a warning letter by the USFDA on June 18.
The facility was inspected by the drug regulator between December 4 and December 15 last year.
The facility was issued an Official Action Indicated (OAI) status on April 11 this year.One of the observations of the USFDA was the fact that Sun Pharma failed to clean, maintain and sanitise equipment at appropriate levels.
NSE
CNBC-TV18 has managed to access the warning letter issued by the United States Food and Drug Administration (USFDA) to Sun Pharmaceuticals Ltd.'s Dadra facility. The observations range from failed to clean and maintain and sanitise equipment along with other repeat observations. Sun Pharma's Dadra facility was issued a warning letter by the USFDA on June 18. The facility was inspected by the drug regulator between December 4 and December 15 last year. The facility was issued an Official Action Indicated (OAI) status on April 11 this year.One of the observations of the USFDA was the fact that Sun Pharma failed to clean, maintain and sanitise equipment at appropriate levels. Another observation stated that there was failure on the company's part to investigate an unexplained discrepancy of a batch or its components.The regulator further said that there have been repeat observations for the Dadra facility and that these repeat violations have been observed at multiple sites of the company, not just Dadra.Repeated failures indicate inadequate oversight and control over manufacturing of drugs, the USFDA stated in its observations. It also said that significant findings are indicating that Sun Pharma does not operate an effective quality system.Therefore, the USFDA has recommended Sun Pharma to engage the services of a consultant which can assist the company in meeting the current good manufacturing practices (cGMP) requirements.Sun Pharma's Dadra unit is involved in the production of oral solid dosage forms and in the manufacturing of the generic Revlimid, which has been a key driver of sales for many pharma companies including Dr. Reddy's, in recent times."We are concerned about the negative outcomes in the audit and I think its our job to find a way to ensure that we come out of whatever the learnings that we have so that we perform better in subsequent audits," Sun Pharma Chairman and Managing Director Dilip Shanghvi had said during its recent earnings call with analysts.Shares of Sun Pharma ended little changed on Tuesday at ₹1,522. The stock has risen 5% in the last one month.
