After receiving a checkered regulatory scorecard in 2024, Aurobindo’s sterile injectables and oncology unit is back in the FDA’s crosshairs. At the same time, a manufacturer of drug ingredients in Tianjin in China has also run afoul of the regulator in the latest round of facility writeups published to the agency’s website.
First up, Aurobindo’s Eugia unit has received an FDA Warning Letter tied to an inspection of its facilities of its Pharma Specialties arm in the Indian city of Hyderabad back in February. Although the drug production specialist responded to a resulting Form 483 on March 20, the FDA has determined that many of Eugia’s proposed remediations were inadequate, leading to the more serious reprimand.
The U.S. regulator flagged two main observations revolving around the physical spaces in which Eugia operators work and lackluster adherence to procedures meant to prevent contamination of sterile drug products.
Eugia’s aseptic processing lines, the FDA wrote, lacked sufficient restricted access barrier systems to allow proper ergonomics when performing manufacturing steps, and they also hindered proper placement and “appropriate physical separation from the surrounding environment,” which the FDA warned are essential to minimizing or eliminating operator intervention in critical clean room environments.
The FDA also noted that it observed operators being allowed to enter certain areas related to the aseptic line “on a frequent basis” to perform manual interventions, among other concerns about Eugia’s overall poor environmental monitoring at the site.
Adding to the FDA’s concerns, the agency noted that it cited Eugia for similar manufacturing violations and aseptic practice issues at other facilities inspected last November and in January.
“Both of these facilities are classified as Official Action Indicated and are in unacceptable CGMP status,” the FDA wrote of the other plants, adding that the “failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs are inadequate.”
Prior to those more recent infractions, Eugia set an especially bad track record with FDA inspectors in 2024.
That August, the company received a warning letter at its Unit III plant in Hyderabad after failing to address concerns the FDA raised at the recently-started plant in February 2024.
Before that, the company had encountered four FDA Form 483s across various sites in its network since late 2023.
Heading north to China, meanwhile, the FDA also doled out a warning letter—published this week—to Kilo Pharmaceutical Sci-Tech following a submission of records related to its active pharmaceutical ingredient (API) plant in Tainjin around July 7.
In looking over the materials, the FDA said it uncovered deviations, in particular flagging the company’s failure to properly register certain products intended for U.S. distribution, among other more production-focused concerns.
On the manufacturing front, the FDA dinged Kilo for failing to show that its process is reproducible and meets necessary quality standards. The agency noted that the company distributed certain ingredients to U.S. compounding pharmacies despite indicating in documents to the FDA that “these APIs were still in development and were not commercial products,” according to the agency.
“Therefore, formal documents such as standard operating procedures had not been finalized,” the FDA added.
The company was also dinged for failing to prepare and use master production and control records, dropping the ball on validation of its testing methods and further stability testing.
On the company’s purported listing violations, the FDA noted that “[y]ou 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.
“Although these drugs are listed in FDA’s drug listing database,” the regulator continued, “they are listed under a different company’s labeler code, not your own.”
The FDA warned Kilo that failing to address any of the deviations outlined in the warning letter could result in the agency’s “continuing to refuse admission of articles manufactured at Tianjin Kilo Pharmaceuticals Sci-Tech Co.”