Generic drug maker Granules India has been criticized by the FDA after inspectors found three trucks full of torn-up manufacturing documents and bird droppings at one of its factories.
On the first morning of the inspection, which ran between Aug. 26 and Sept. 6, the agency found the trucks full of shredded manufacturing and analytical documents leaving the facility in Telangana, India, according to a 26-page Form 483 published on Tuesday.
The documents included handwritten worksheets, testing information and printouts of analytical balance sheets. A staffer was also seen removing a large bag full of both torn and intact documents from the quality control lab. After putting together the scraps of paper, the FDA inspectors confirmed the documents were original records of raw data for quality control and “should not have been destroyed.”
The regulator also cited issues with the facility’s upkeep and cleanliness. Inspectors found bird droppings and feathers on air handling units, water tanks and the factory floor, and noted that the factory walls were not secure enough to stop birds from flying in.
The FDA found a total of six issues. These included a record of certain manufacturing equipment having not been cleaned for several years since installation, leading to a buildup of white and off-white powder, indicative of potential bacteria, mold and fungi. Further, the water tank showed signs of rust, microbial, yeast and mold growth.
Hyderabad-headquartered Granules manufactures API and drugs, and it also has an R&D arm.