The U.S. Food and Drug Administration (FDA) has issued warning letters to Aurobindo Pharma’s sterile injectables and oncology subsidiary Eugia Pharma Specialities and to Tianjin Kilo Pharmaceutical Sci-Tech Co. in China, citing manufacturing and compliance concerns at both companies’ facilities.
The warning letter to Eugia followed an FDA inspection conducted in February at the company’s Pharma Specialties facility in Hyderabad, India. Although the company responded to a Form 483 issued after the inspection on March 20, the FDA concluded that several of the corrective actions proposed by the manufacturer were insufficient, resulting in the warning letter.
FDA Raises Concerns Over Eugia’s Sterile Manufacturing Practices
According to the FDA, two primary issues were identified at the Hyderabad site. The agency cited deficiencies related to the physical setup of manufacturing areas and shortcomings in procedures intended to prevent contamination of sterile drug products.
Inspectors found that the facility’s aseptic processing lines lacked adequate restricted access barrier systems. The FDA said the design of these systems did not support proper ergonomics during manufacturing activities and also interfered with appropriate placement and physical separation from the surrounding environment. The agency stated that these measures are essential to minimizing or eliminating operator intervention in critical cleanroom environments.
The regulator also observed that operators frequently entered areas associated with the aseptic processing line to perform manual interventions. In addition, FDA inspectors raised concerns regarding the facility’s environmental monitoring practices.
Previous Inspections Referenced in Warning Letter
The FDA noted that similar manufacturing and aseptic processing deficiencies had been identified at other Eugia facilities inspected in November and January.
In the warning letter, the agency wrote, “Both of these facilities are classified as Official Action Indicated and are in unacceptable CGMP status.” The FDA added that the failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs are inadequate.
In August 2024, the company received a warning letter for its Unit III facility in Hyderabad after failing to adequately address concerns raised during an FDA inspection conducted earlier that year. Prior to that warning letter, the company had received four FDA Form 483 observations across different facilities within its manufacturing network since late 2023.
Tianjin Kilo Cited for Manufacturing and Listing Deficiencies
Separately, the FDA issued a warning letter to Tianjin Kilo Pharmaceutical Sci-Tech Co. after reviewing records related to its active pharmaceutical ingredient (API) manufacturing facility in Tianjin, China. The materials were submitted to the agency around July 7.
During its review, the FDA identified multiple deviations, including concerns regarding the registration of products intended for distribution in the United States. The agency also questioned whether the company had adequately demonstrated that its manufacturing processes were reproducible and capable of consistently meeting required quality standards.
The FDA further stated that Tianjin Kilo supplied certain ingredients to U.S. compounding pharmacies even though documents submitted to the agency indicated that those APIs remained in development and were not commercial products. The agency noted that formal procedures had not yet been finalized for those products.
Additional observations included failures to prepare and use master production and control records, deficiencies in validating testing methods, and shortcomings related to stability testing.
FDA Warns of Potential Import Consequences
The agency also cited product listing issues involving demecarium bromide and chlorambucil. According to the FDA, the company manufactured and shipped these drugs to the United States without providing drug listing information under its own labeler code. While the products appeared in the FDA’s drug listing database, they were listed under another company’s labeler code.
The FDA warned Tianjin Kilo that failure to correct the deficiencies outlined in the warning letter could lead to the continued refusal of admission of products manufactured at the company’s Tianjin facility into the United States.
Aurobindo Pharma’s Eugia Pharma Specialities unit has received an FDA Warning Letter following an inspection of its manufacturing facility in Hyderabad, India. The FDA cited significant violations of current good manufacturing practice requirements for finished pharmaceuticals.
The Aurobindo-linked Eugia facility was inspected from February 16 through February 27, 2026. FDA officials reviewed the company’s response to inspection findings and determined that important manufacturing concerns remained unresolved.
Aurobindo Faces Sterile Manufacturing Concerns
The FDA raised concerns about the facility’s aseptic processing operations. According to the agency, some production lines did not have sufficient restricted access barrier system features to provide appropriate separation and support contamination control.
The FDA stated that failure to address the Eugia violations could result in refusal of admission for certain articles manufactured at the facility. The agency may also withhold approval of new applications or supplements listing the facility as a manufacturer until the violations are adequately resolved.
For Aurobindo, resolving the warning will therefore be important not only for regulatory compliance but also for maintaining reliable access to the U.S. pharmaceutical market.
Aurobindo Must Strengthen Quality Controls
The latest warning reinforces the importance of robust quality systems throughout pharmaceutical manufacturing. For Aurobindo, strengthening aseptic processing controls, facility design, contamination prevention, and management oversight will be central to addressing the FDA’s concerns.
The company will need to demonstrate sustained compliance rather than simply provide short-term corrective measures.
Aurobindo’s Regulatory Outlook
The FDA’s warning letter does not itself represent a final determination that all products from Aurobindo are unsafe. Instead, it identifies specific regulatory violations that the company is expected to investigate and correct.
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