The U.S. FDA issued a warning letter to Aurobindo Pharmaceutical regarding violations of current good manufacturing practice for active pharmaceutical ingredients at a plant in Telangana, India.
The warning letter comes following an August 2021 site inspection that resulted in the agency issuing a 483. In the Jan. 2022 letter, the FDA noted the facility failed to fulfill several requirements, including a failure to evaluate the potential effect that changes in quality may have had on the quality of intermediates and API, and failure of the quality unit to ensure that critical deviations are investigated and resolved.
Aurobindo, one of India’s biggest drug manufacturers, failed to fully evaluate how changing drug manufacturing conditions would impact the API and did not fully investigate discrepancies, according to the FDA. In response to the notice, Aurobindo is responsible for providing an independent assessment of the overall system to investigate deviations, discrepancies, complaints, OOS results and failures. The FDA requested Aurobindo provide a detailed action plan for remedying the errors.
Failure to correct the violations may result in the FDA withholding approval for future drug applications, the agency noted.
The warning letter is not the first time the company has been in hot water, and the FDA made sure Aurobindo didn't forget that by noting, "Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate."
In 2019, Aurobindo reported that it had received 10 observations from the FDA after an inspection of its “Unit III” formulation plant in Telangana found troubling quality control issues related to data management and laboratory cleaning practices, ranging from loose handwritten notes of lab results to open buckets of water in labs.
In October 2020, a New Jersey-based facility owned by Aurobindo also received a warning letter from the FDA for failing to maintain buildings properly and follow written procedures for cleaning and maintenance of equipment.
