Aurobindo Pharma’s sterile injectables and oncology division Eugia has received a fresh FDA Warning Letter following an inspection of its Pharma Specialties facilities in Hyderabad in February.
The warning letter comes after Eugia submitted its response to a resulting Form 483 on March 20, which the FDA determined contained inadequate proposed remediations.
Regulators identified two primary observations concerning the physical workspaces used by Eugia operators and weak adherence to contamination prevention procedures for sterile drug products.
The FDA found that Eugia’s aseptic processing lines lacked sufficient restricted access barrier systems to ensure proper ergonomics during manufacturing steps.
The agency also warned that the setup hindered proper placement and “appropriate physical separation from the surrounding environment,” which it described as essential to minimising operator intervention in critical clean room environments.
Inspectors additionally observed that operators were permitted to enter areas related to the aseptic line “on a frequent basis” to perform manual interventions, raising further concerns about the site’s environmental monitoring practices.
The FDA noted that it had previously cited Eugia for similar violations at other facilities inspected in November and January, stating that “both of these facilities are classified as Official Action Indicated and are in unacceptable CGMP status.”
The agency added that the “failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs are inadequate,” signalling deep concern about company-wide compliance culture.
Eugia’s regulatory difficulties are not new, as the company received a warning letter at its Unit III plant in Hyderabad in August 2024 after failing to address concerns raised by the FDA earlier that year.
Prior to that, the company had accumulated four FDA Form 483s across various sites in its network since late 2023, building a pattern of repeated non-compliance.
Separately, the FDA has also issued a warning letter to Kilo Pharmaceutical Sci-Tech following a review of records related to its active pharmaceutical ingredient plant in Tianjin, China, submitted around July 7.
Inspectors identified deviations including a failure to properly register certain products intended for distribution in the United States market.
On manufacturing quality, the FDA dinged Kilo for failing to demonstrate that its production process is reproducible and meets necessary quality standards.
The agency noted that Kilo distributed certain ingredients to US compounding pharmacies despite documents submitted to the FDA indicating “these APIs were still in development and were not commercial products.”
“Therefore, formal documents such as standard operating procedures had not been finalised,” the FDA added, highlighting the seriousness of the procedural lapses.
Kilo was also cited for failing to prepare and use master production and control records, and for deficiencies in the validation of testing methods and stability testing protocols.
On listing violations, the FDA stated that Kilo “did not provide drug listing information for demecarium bromide and chlorambucil under your own labeler code, yet you manufactured and shipped these drugs into the United States.”
The regulator further noted that while the drugs appear in FDA’s drug listing database, “they are listed under a different company’s labeler code, not your own,” representing a significant compliance breach.
The FDA warned Kilo that failure to address the outlined deviations could result in the agency “continuing to refuse admission of articles manufactured at Tianjin Kilo Pharmaceuticals Sci-Tech Co.”
Both cases reflect ongoing regulatory pressure on overseas pharmaceutical manufacturers supplying products to the US market, with the FDA showing little tolerance for repeated or unaddressed manufacturing shortfalls.