The Form 483 comes after the US Food and Drug Administration (FDA) conducted an inspection at the facility in Hyderabad, India, in December 2018. During the inspection, the agency noticed that procedures to prevent microbiological contamination of drug products were not followed.
Only two observations were made, but the FDA’s report spans twelve-pages – detailing improper set-up of lines for aseptic filling of drug products for the US drug market and the mishandling of primary packaging components.
The first observation stated that active-air sample results from the aseptic filling line could not be assured of presenting proper air quality throughout the filling. It also noted that procedures for air monitoring using the settling plates to monitor the filling area were not at working level.
The second observation of the two is in regards to protective apparel that is to be worn to protect drug products from contamination. Operators provided no assurance that the required apparel is worn in the aseptic production areas, which could lead to possible contamination.
In March 2018, the same injectables facility received nine observations from the FDA, including signs of rodents and insects.
Another Aurobindo facility was issued a Form 483 regarding procedural issues in September 2017. The antibiotics manufacturing facility in Andhra Pradesh, India, received a Form 483 after the FDA observed a lack of written produces to assure strength, quality, purity, and drug identity.