Aurobindo’s Eugia Facility Classified OAI: Deficient Aseptic Practices

Aurobindo’s Eugia Pharma Specialities Limited (FEI 3011960448), located at Shameerpet, India, has been classified OAI (Official Action Indicated) by the USFDA. The inspection, conducted in February 2026 by FDA investigators Joseph A. Piechocki and Matthew B. Casale, revealed significant cGMP deviations in aseptic processing, microbial contamination control procedures, and complaint investigations.

Inadequate Microbiological Controls in Sterile Manufacturing

Environmental Monitoring & Grade A Area Controls:

Lapses were noted in classification and monitoring of Grade A areas where aseptic connections are performed. This area is not held to Grade A classification during this critical operation with a specification of “No Growth”.

Operator Practices:

Exposed areas / equipment was not sanitized after contact with operator garments. All interventions on conveyor/filling lines were not covered by smoke studies or written procedures and areas are not completely disinfected after reassembly. Operators were observed leaning over transfer lines and open sterile vials, increasing contamination risk.

Post-Intervention Monitoring:

Personnel monitoring was not consistently performed after interventions.

Lapses in aseptic process validation:

For a product last aseptic process simulation was conducted in July 2022, though the product continue to be manufactured with several shipments made to US since May 2024.

Deficiencies in complaint investigations

The Firms investigations into of complaints and Filed Alert Report (FAR) incidents were also found lacking. Multiple complaints were reported with glass pieces measuring to 18mm and 15 mm in glass injection vials. The investigations could not identify the source of the glass, but root cause was attributed to vials breaking and corrective and preventive actions were implemented including new visual inspection challenge for larger glass pieces and requalification of visual inspectors. But the investigations did not evaluate suitability of the glass vials for the product and why the visual inspection process did not identify the glass pieces.

Visual Inspector Qualification:

It was also observed that the visual inspection process do not assure ongoing qualification and challenge employees’ visual inspection skills; (some) challenges were being performed only at the time of initial qualification and not at subsequent requalification

Container Closure System suitability: Furthermore, despite numerous complaints and Field Alert Reports (FAR) over two years on two products, investigations did not reassess container closure suitability.

Key Takeaways

Sterile facilities remain a high-priority focus for USFDA inspections due to the elevated risk of microbial contamination and its serious patient safety implications. USFDA inspections in sterile facilities focus on:

• Contamination Control Strategy (CCS)
• First-Air Integrity / violations
• Aseptic Process Validation (media fills)
• Facility design and control
• Operator aseptic practices
• Visual inspections

FDA inspectors routinely review live batch operations, CCTV footages, smoke studies, and media fills to identify procedural lapses, risky interventions and aseptic practices. Lapses in operator practices in aseptic operations, first air violations, airflow controls / turbulence in critical areas, media fill studies failing to cover all operator interventions are some of the most frequently cited deficiencies in sterile facilities.

Effective training of personnel in aseptic practices, regular monitoring of aseptic operations, periodic media fill studies covering all critical operator interventions, affirmative actions in case of deviations including impact assessment and recall (where required) are absolutely essential to ensure product safety and integrity and successful regulatory inspection.

• USFDA 483: Eugia Pharma (February 2026)
• Aurobindo Press Note (May 2026)