FDA Warning Letter: Aseptic Processes strongly Criticised

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Eugia Pharma Specialities Limited on August 13, 2026, citing significant violations of Current Good Manufacturing Practice (CGMP) requirements. The letter concerns Unit 1 of the company’s facility in Telangana, India, which was inspected from February 16 to 27, 2026. The findings primarily relate to sterile injectable drug products manufactured through aseptic processing.

A central issue in the warning letter is the design of the aseptic processing lines and their Restricted Access Barrier Systems (RABS). According to the FDA, parts of the lines were not adequately separated from the surrounding environment and therefore did not reliably function as effective barriers protecting critical ISO 5 areas. The agency identified deficiencies involving ergonomics, component placement and the physical separation between ISO 5 and ISO 7 areas. As a result, operators were able to intervene repeatedly in parts of the aseptic line during setup and routine production. In the FDA’s assessment, the frequency of these manual interventions increased the risk of contamination of critical surfaces, open vials and product-contact equipment.

Particularly concerning were interventions in areas where RABS protection was not consistently maintained. During certain activities, operators reached over open process or transfer areas. RABS openings on opposing sides of the production line were also left open for extended periods, while additional cleanroom doors or access points were opened. The FDA considered this an unnecessary exposure of the aseptic processing environment to lower-quality surrounding air. During component installation, inspectors observed operators touching sterile parts of the system or allowing gown sleeves to brush against open components. Adequate disinfection after these events was not consistently ensured.

The FDA therefore viewed the problems as more than isolated operator errors. Aseptic equipment and processes must be designed to eliminate or technically control critical interventions wherever possible. Eugia’s proposed response included additional disinfection measures, operator training, sterile-to-sterile connectors and revised process simulations. The agency considered these measures insufficient because they did not adequately address the underlying equipment design deficiencies or provide a firm commitment to a more extensive redesign of the aseptic operations and processing lines.

The FDA also criticized the facility’s environmental monitoring program. Certain extended ISO 5 areas where critical aseptic connections were performed were not adequately held to ISO 5 limits. In addition, the process simulations, or media fills, did not represent all critical interventions carried out during commercial manufacturing. The agency cited, as an example, an aseptic connection relevant to the manufacture of certain injectable products that was not included in the corresponding simulation requalification. As a result, the media fills did not fully represent the actual worst-case conditions of the production process.

The concerns are amplified by the FDA’s finding that similar deficiencies involving aseptic practices and processing-line design had already been identified at Eugia’s Units II and III. The recurrence of comparable findings across multiple facilities, according to the agency, suggests inadequate management responsibility and ineffective global quality oversight. Eugia is therefore expected to assess not only the affected facility but also its worldwide manufacturing and quality systems. Read the full Warning Letter on the FDA website.