US FDA flags quality, hygiene issues at Aurobindo Pharma's Unit III
Informist, Friday, Aug 25, 2023
--US FDA flags quality, hygiene issues at Aurobindo Pharma's Unit III
--US FDA saw foreign particles in sample at Aurobindo Pharma's unit
--US FDA: Ceiling leak found at Aurobindo Pharma Unit III
--US FDA: Equipment hygiene norms not fixed at Aurobindo Pharma unit
By Apoorva Choubey
MUMBAI – The US Food and Drug Administration has found Aurobindo Pharma Ltd's oral drugs unit in Bachupally, Telangana, non-compliant with the established quality control and sanitation norms, documents sourced from the drug regulator showed.
The agency had issued three observations to Aurobindo Pharma's Unit III in the Medchal Malkagiri district after inspecting it from Jul 14-21. However, details pertaining to the observations were not disclosed, as is the standard in the industry.
The sourced documents show that the most serious observation listed out by the US regulator was that the drugmaker's facility was found to be deficient in laboratory control mechanisms.
During an inspectional walkthrough of the quality control laboratory and testing area, US FDA auditors observed that a certain testing sample appeared to have solid, dark-coloured flakes and particles floating in it, the document said. The laboratory staff was unable to explain the presence of these unexpected particles or even identify them.
Another observation flagged was the lack of proper hygiene at the facility, as inspectors found buildings used in the manufacture, process, packing or holding of drug products were not maintained in a clean and sanitary condition.
On Jul 20, during a walkthrough in the quality control laboratory, the agency found part of the ceiling leaking and the leak was next to a pharmaceutical refrigerator being used to store chemicals for analytical testing. The ceiling also contained water stains, the auditors noted.
The third deficiency was that written procedures were not established for cleaning and maintenance of equipment, including utensils, used in the manufacturing and processing of drugs.
The US FDA withheld the information specific to the drugs and samples inspected.
Aurobindo Pharma manufactures oral formulation products related to non-cephalosporins and non-beta-lactams at the facility.
On the National Stock Exchange today, shares of the company closed 0.6% lower at 828.50 rupees. End
