USFDA raps Aurobindo Pharma

‘Responsibilities and procedures applicable to quality control unit not fully followed’

A team of the US Food and Drug Administration (USFDA) that inspected a formulation plant of Aurobindo Pharma in Mahabubnagar, Telangana, last month has observed that several documents provided were either incomplete or inaccurate.

“The responsibilities and procedures applicable to the quality control unit are not fully followed. Several lists of documents requested were either provided as incomplete, inaccurate and/or explained with potentially misleading statements throughout the inspection,” details of the observations made by the team and available on the USFDA website said.

In another observation, the USFDA team’s said “equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.”

The other observations include: “Written production and process control procedures are not followed in the execution of production and process control functions” and “laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with establishment specifications and standards”.

The USFDA had conducted the cGMP (current good manufacturing practices) inspection of the unit from September 19-27. On October 7, the company had said that the inspection of the unit had ended with seven observations.

“We believe none of the observations are related to data integrity. The company is confident of addressing these issues within the stipulated timeline,” Aurobindo Pharma had informed the stock exchange.

A letter from the Editor

Dear reader,

We have been keeping you up-to-date with information on the developments in India and the world that have a bearing on our health and wellbeing, our lives and livelihoods, during these difficult times. To enable wide dissemination of news that is in public interest, we have increased the number of articles that can be read free, and extended free trial periods. However, we have a request for those who can afford to subscribe: please do. As we fight disinformation and misinformation, and keep apace with the happenings, we need to commit greater resources to news gathering operations. We promise to deliver quality journalism that stays away from vested interest and political propaganda.

Support Quality Journalism
Recommended for you
This article is closed for comments.
Please Email the Editor

Printable version | May 27, 2020 8:13:22 PM | https://www.thehindu.com/news/cities/Hyderabad/usfda-raps-aurobindo-pharma/article29649678.ece

Next Story