FDA Warns Aurobindo Pharma’s Eugia Unit
FDA has issued a warning letter to a Telangana, India, sterile drug manufacturing facility operated by Aurobindo Pharma subsidiary Eugia Pharma Specialities, following a February inspection (see earlier story) that identified deficiencies involving aseptic manufacturing, process validation, visual inspection and investigations of complaints involving glass particles. The agency subsequently classified the facility as Official Action Indicated (OAI).
Aurobindo disclosed the Warning Letter 8/14, saying the facility has received the letter following the OAI classification. The company said there is no impact on existing supplies to the U.S. market and that the unit accounts for about 2% of Aurobindo’s overall group revenue.
The FDA Form 483 underlying the action identified deficiencies in controls intended to prevent microbiological contamination of sterile products. Investigators found that certain critical aseptic operations were not adequately controlled, including problems with environmental and personnel monitoring, operator interventions in Grade A areas and practices that could compromise sterile product. FDA also found that an aseptic process simulation, or media fill, had not been conducted since July 2022 for a product intended for the U.S. market, despite at least 16 batches being shipped to the U.S. since March 2024.
FDA also cited deficiencies in the qualification of employees conducting visual inspection of sterile finished products. Investigators found that employees were not being appropriately challenged during subsequent requalification after their initial qualification. The agency separately faulted Eugia’s handling of investigations involving complaints and potential field alerts. In one case, consumers reported finding 18-mm and 15-mm pieces of glass in injectable drug vials. Although the investigations attributed the problem to vial breakage, FDA said the investigations did not adequately establish why the visual inspection process failed to detect the glass or whether the vial/container-closure systems remained suitable.
The inspection also found a substantial complaint history involving certain injectable products. FDA said one product generated 388 complaints over two years, resulting in seven field alert reports, while another generated 231 complaints and 57 field alert reports. Despite those reports, the facility had not reviewed the container-closure systems for either product since the products were initially marketed to determine whether the systems remained appropriate in light of the complaints.
The Eugia action is separate from FDA's recent regulatory scrutiny of another Aurobindo/Eugia facility in Telangana. Unit-III underwent an FDA inspection from 1/27 through 2/6 that generated 11 observations (see earlier story).
Aurobindo said it remains committed to working with FDA and continuing to strengthen compliance at its manufacturing facilities.