Aurobindo’s sterile drug product facility, located in Telangana, India, received a Form 483 from the US Food and Drug Administration (FDA) that contained 11 observations in total, after an inspection that took place between February 22 and March 1 of 2019.
The site inspection saw the agency conclude that “[Aurobindo’s] Quality Unit has not performed the necessary assessments/reviews to ensure that the objectionable conditions do not negatively affect the aseptic manufacturing processes and Quality Control tests.”
The second observation by the FDA notes that the firm received 12 complaints regarding particulate matter found in nine batches of injections and vials, with the FDA redacting the specific products in its release.
In particular, the report noted that black particles were found floating in vials in one batch, and dark red and black specks were found in another batch. During the company’s internal inspection, neither forms of particulate were assigned a probable cause and, instead, it was suggested that the particles were “intrinsic to the manufacturing process.”
A further observation noted that employees involved in quality control were not adequately trained to perform their assigned function.
The inspection report also stated that the visual inspection process did not include a 360-degree inspection of drug product vials. According to the inspectors, “Body mechanics precluded an individual from twisting their wrist in a way to allow for inspection of the back side of the vials.”
For Aurobindo, this is the second Form 483 that it has received in the last month, after its Hyderabad, India, was also cited as having issues in a 12-page report.
The FDA action comes as the India-headquartered company consolidates its presence in the US market, with the $900m (€779m) purchase of Novartis generic oral solids and dermatology business.