USFDA warns Aurobindo’s Eugia Pharma over sterile drug manufacturing lapses | Hyderabad News

Hyderabad: The United States Food and Drug Administration (USFDA) has issued a warning letter to Eugia Pharma Specialities Ltd’s Unit-I in Telangana after its inspection found lapses in contamination controls, aseptic process validation, visual inspection of sterile drugs and investigations into complaints, including cases involving glass pieces in injection vials.Eugia Pharma Specialities is a wholly owned subsidiary of Hyderabad-based Aurobindo Pharma Ltd. The unit-I facility at Kolthur village in Shameerpet mandal manufactures sterile pharmaceutical products.Aurobindo informed the stock exchanges on Aug 14 that the warning followed the USFDA’s earlier classification of the facility as “Official Action Indicated” (OAI). The company said existing supplies to the US market were not affected and that the unit accounts for about 2% of the group’s overall revenue.Aurobindo said it remained committed to working closely with the USFDA and to enhancing compliance on an ongoing basis.Four observations after Feb inspectionThe regulatory action traces back to a USFDA inspection conducted from Feb 16 to Feb 27. At the end of the inspection, the agency issued a form containing four observations.One of the main observations concerned the facility’s procedures to prevent microbiological contamination of products meant to be sterile.According to the Form 483, environmental and personnel monitoring in critical laminar airflow (LAF) areas was inadequate. A critical operation zone reclassified as Grade A-Air was not subjected to Grade A specifications requiring “No Growth” during critical aseptic connections, while operators were not immediately monitored after completing such connections.Inspectors also observed operators’ garments touching exposed Grade A sections of sterile filling lines without the affected portions subsequently being sanitised.The USFDA further flagged personnel interventions around conveyor belts that did not conform with smoke studies or written procedures. Operators were not monitored after some interventions and areas beneath conveyor belts were not completely disinfected after reassembly.Closed-circuit television (CCTV) footage reviewed during the inspection showed operators leaning over and covering openings of sterile product transfer lines before making connections. Interventions to remove fallen vials also did not ensure that tools or hands remained clear of open sterile vials.Aseptic validation, visual checks flaggedThe second observation related to validation of aseptic manufacturing. The facility had not conducted an aseptic process simulation, or media fill, since July 2022 for a particular drug product strength intended for the US market. Batches of the product had nevertheless been shipped to the US since March 2024.The USFDA also raised concerns over visual inspection controls. Employees inspecting finished sterile pharmaceutical products had been qualified only during their initial testing and were not subsequently challenged or requalified. For several employees, their last qualification dated back several years.The fourth observation dealt with investigations into unexplained discrepancies and failures, including products that had already been distributed.Two investigations had been opened after consumer complaints involving glass pieces measuring 18 mm and 15 mm in dispensed vials of an injection product. The facility attributed the problem to vials breaking in machinery and fragments entering otherwise intact vials. The inspection, however, found that the investigation did not assess whether the glass vials remained suitable or explain why visual inspection had failed to detect the pieces under unchanged operating conditions.Container systems not reviewedThe Form 483 also cited complaint trends involving container closure systems. The facility had received 388 complaints concerning one issue, resulting in 77 Field Alert Reports, and another 231 complaints concerning a separate issue, resulting in 57 Field Alert Reports over two years.Despite these complaints, the USFDA observation said the container closure systems for the two products had not been reviewed since they were first marketed to determine whether they continued to be appropriate.Following the Feb inspection, Aurobindo had informed the National Stock Exchange (NSE) and BSE Ltd on Feb 27 that Unit-I had received four observations. The USFDA classified the facility as OAI on May 23, and Aurobindo disclosed the classification to the exchanges the following day.