USFDA finds several violations in Aurobindo sterile injections unit
FDA investigators have observed violations in sterilisation process to prevent microbial contamination and shortcomings in facility management procedures along with lapses in the design of the manufacturing plant.
It said the unit does not follow established test procedures, and that senior company managers confirmed to investigators that cleaning and sanitising is not done periodically. Form 483 listed 14 observations. Specifically, it found records of inspections of automatic, mechanical or electronic equipment, including computers or related system were not maintained.
FDA investigators also found that the laboratory does not perform enough quality control check to ensure analysts are performing tests adequately on a consistent basis. “Laboratory records are deficient in that they do not include the initials and signatures of the person performing the tests and dates tests were performed,” the report said.
It also noted that employees are not given training in particular operations they perform, and observed lapses in the leachability studies and biocompatibility studies. The unit IV is Aurobindo’s key injectable formulations plant, accounting for 9-10% of the firm’s US sales and 50-60% of its total injectable sales in FY19. The plant also accounted for 8-9% of the company’s overall operating profit during the period. Aurobindo will now have to respond to FDA with corrective measures to get the plant cleared within a stipulated time.
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