The FDA issued Aurobindo Pharma a Form 483, citing six observations related to procedural improvements at the company’s Unit III facility at Bachupally in Hyderabad, India.
All of the observations cited in the regulatory agency’s letter are related to procedural improvements, and "none of the observations are related to data integrity," the company said in a filing with the Bombay Stock Exchange.
FDA inspectors reviewed the facility, which manufactures oral formulations that include antiretroviral drugs, from April 10 to 18. Aurobindo added that the U.S. regulatory agency’s findings will have “no material impact” on the company.
About 55% of Aurobindo’s $556 million in revenues in fiscal 2016 came from sales of finished drugs in the U.S.
The company has been focused on building its business in the U.S. In February, it announced plans to build a second sterile injectables plant at its site in New Jersey. Last summer, the company began construction on a 567,000-square-foot facility in New Jersey, which will include a manufacturing and distribution center and warehouse. Between 400 and 500 people will be employed when the facility opens.
Aurobindo also announced last year that it will invest $31.7 million to turn a former medical facility in Durham, North Carolina, into a manufacturing site that would employ up to 275 workers.