India’s Aurobindo Pharma last month acknowledged that it had received an FDA Form 483 for a sterile injectables plant in Bachupally, a suburb of Hyderabad, but stressed that there were no observations having to do with data integrity. Perhaps so, but according to a new report, the FDA was concerned about problems that could lead to contamination of products.
According to a report by Livemint, which has obtained a copy of the Form 483, among the six observations were FDA citations for problems in procedures that are supposed to prevent microbiological contamination of sterile products.
But more issues came out of the April inspection. Investigators noted that the plant building and equipment were not being properly maintained.
While Aurobindo said that there were no issues around data integrity, the inspectors did note that the plant didn’t have appropriate safeguards on computers to prevent records from being altered. There were also observations that changes to written procedures were not drafted, reviewed and approved by the appropriate employees and and batch distribution records were not being thoroughly reviewed, the newspaper reported.
The finding comes even as the Indian drugmaker is expanding its sterile production in the U.S. and India. 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.
At about the same time, the company said that it had already started work on manufacturing facility in Hyderabad, Telangana, to produce biosimilars. It said it expects the plant to be complete in the second quarter of fiscal 2018, which would mean sometime in the second half of this calendar year.
The India facility plant will be used to produce four biosimilar candidates that it acquired this year in a deal with Switzerland-based TL Biopharmaceutical. Details on the deal were scarce, but it said they include three oncology monoclonal antibodies, including bevacizumab, a biosimilar of Roche’s cancer drug Avastin. It said in the announcement that it would expand the four products picked up from TL with eight more biosimilars it intends to develop.