Most of the observations relate to deficiencies in maintaining equipment, cleanliness of equipment and utensils, sterility, employees training, lab controls and computer controls
Drug maker Aurobindo Pharma has received nine Form 483 observations from the USFDA for its Unit IV injectable facility.
The USFDA had conducted an inspection at the company’s Unit IV from February 12 to February 20.
Unit IV is located in Pashamailaram near Hyderabad and sterile injectables and opthalmics are manufactured here.
The company in a statement to stock exchanges said - none of the observations are related to data integrity or repetitive in nature.
"We are in the midst of providing a comprehensive response to the observations and would be replying to the FDA within 15 working days from the date of closure (20th February, 2018) of audit," the statement added.
A Form 483 is issued by the US FDA at the end of the inspection stating any deviations of good manufacturing practices. The company will have to file its response in 15 days stating corrective and preventive action plan referred at CAPA. Any failure to respond to the satisfaction of the agency may further escalate to warning letter and in some worst cases even an import ban.
The plant contributes about 15 percent of US sales, and is significant for the future of the company because around a third of company's total generic filings that are pending for approvals are filed from this facility. Much of these products filed from Unit 4 are part of high margin complex portfolio.
The company has been looking at sales of $180-185 million from the unit by the end of the ongoing financial year and increase to about $250 million by the year through March 2020.
Aurobindo has 114 filings under review as on December 31.
Most of the observations relate to deficiencies in maintaining equipment, cleanliness of equipment and utensils, sterility, employees training, lab controls and computer controls, according to the U.S. Food and Drug Administration’s Form 483 reported by CNBC-TV18.
Injectable plants which make sterile products are usually subjected to much tighter scrutiny - the frequency of inspections by the USFDA for injectables is also higher- once or twice in a year against once in one and half to two years for oral solids. Hence, chances of observations are higher in case of injectables.
Though none of the observations are related to data integrity or root cause investigations - but the observations indicate that the company was found wanting in basic GMP hygeine requirements such as maintenance of equipment and cleaniliness.Shares of Aurobindo dropped 3.65 percent and were trading at Rs 601.35 on BSE at 1.50 pm, the benchmark Sensex declined 0.92 percent to 33,733.49 points.