FDA shines light on Indian manufacturer’s misgivings at one of its facilities
Last month, Indian drug manufacturer Aurobindo Pharma let the national stock exchange know that they once again invoked the ire of US regulators. Now the ‘Form 483’ shines a light on what exactly went wrong.
According to the form, several observations were made at Aurobindo’s Unit VII formulation plant in the village of Polepally, India during an inspection in early May.
Investigators found an unexplained discrepancy and a failure of a batch of its components to meet any of its specifications. The FDA found out specification (OOS) assay and dissolution results had led to the rejections of four tablet batches which were identified by a lack of control over compression machine settings.
Other observations that were witnessed included there being no written procedures for production and process controls as well as batch production and control records not including complete information relating to the production and control of each batch. Also, the written stability testing program had not been followed.
The FDA also found controls not being exercised over computers and equipment used in the manufacture, processing, packing, or holding of drug products not being of appropriate design to facilitate operations for its intended use.
This marks the 15th time that Aurobindo has gotten the 483 slap since 2016 and the second time this site, in particular, has been cited. In 2019, the plant had seven observations including written procedures not being followed, unclean materials, quality control not being followed and a failure to review any discrepancies, among other warnings.
Upon being notified back in May, the manufacturer notified the National Stock Exchange of India in a letter that it had received the 483 and that “The Company will respond to the US FDA within the stipulated timeline and work closely with US FDA to close the observations,” the letter said.
Despite the company being one of the larger drug manufacturers, this notice has not been a confidence booster to Aurobindo on the exchange, as the company $AUROPHARMA has seen a 14% drop in its price over the past month and a 28% decrease year to date.
Aurobindo’s woes also now extend to a court in the US, as a group of plaintiffs, including J&J’s Janssen unit and the Sloan Kettering Institute for Cancer Research, filed a lawsuit against Aurobindo accusing it of applying to market an Erleada copycat before five patents are up.