The United States Food and Drug Administration (US FDA) released the details of the warning letter it sent to Aurobindo Pharma’s Hyderabad Active Pharmaceutical Ingredients (API) Unit on Thursday.
USFDA flagged violation of current good manufacturing practice (CGMP) for active pharmaceutical ingredients. It had inspected the company’s drug manufacturing facility at Doultabad, Telangana, in August last year.
According to the US drugs regulatory body, repeat deviations demonstrate that oversight over the manufacturing of drugs was Inadequate and the pharma firm failed to evaluate changes that were impacting the quality of intermediates and API.
Aurobindo Pharma also failed to ensure that critical deviations are investigated and resolved, US FDA said
in its letter.
"Your firm failed to fully evaluate whether increasing your acceptable (b)(4) limit by (b)(4) in an (b)(4) API starting material (b)(4) would impact the quality of (b)(4) API….. instead of fully evaluating the effect of increasing the (b)(4) limit in the (b)(4) starting material, you relied on an (b)(4) step as part of your lab scale study, which was not a part of the approved or implemented large scale manufacturing process for the (b)(4) API at the time, to purge potential impurities without demonstrating that any potential impurities would be removed by (b)(4)," it told Aurobindo Pharma in the letter.
The regulatory body has recommended the pharma firm to engage with a consultant to assist in meeting current good manufacturing practice (CGMP) requirements.
Earlier this month when the pharma firm informed the stock exchanges about the warning letter, it said it would engage with the regulator and is fully committed to resolve the issue at the earliest. The company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe, it added.
FDA has warned that it may withhold approval until any deviations are fully addressed and may reinspect to verify completion of corrective actions. It has sought a comprehensive, independent assessment of the overall system for investigating deviations, discrepancies, complaints, out-of-specification (OOS) results, and failures, and a detailed action plan to remediate this system.
It has directed Aurobindo Pharma to hold a retrospective, independent review of all invalidated OOS (including in-process and release/stability testing) results for US products irrespective of whether the batch was ultimately distributed in the US for the last three years from the initial date of inspection and a report summarizing the findings of the analysis, including the following for each OOS.
The US regulatory body has also demanded a review of all analytical and microbiological method transfers for any discrepancies not described in the approved method transfer reports.
The warning letter follows the inspection of the Hyderabad unit by the US FDA
in August 2021.
Later in November last year, Aurobindo Pharma
had said that the US drug regulator had classified the inspection conducted at its Unit I in Hyderabad between August 2-12, 2021 as Official Action Indicated (OAI).
The company’s Unit-1 makes active pharmaceutical ingredients and the US drug regulator, in November, had issued Form 483 with seven observations to Unit I.
After US FDA released the details of the warning letter, Aurobindo Pharma stock slipped 3.75 percent to an intraday low of Rs 594 on the Bombay Stock Exchange (BSE).
(Edited by : Kanishka Sarkar)