Indian API Plant Receives FDA 483

Indian API Plant Receives FDA 483

April 19th, 2022 // 1:31 pm @

The Indian API company Lupin has been criticized by FDA before. After it was cited for inadequate manufacturing operations and other cGMP violations last summer, the genetics drug company still has not cleaned up its operations.

Now Lupin’s API plant in Tarapour, India has been hit by an FDA 483 after an FDA inspection from March 22 to April 4, 2022.

FDA blasted Tarapour for poor manufacturing processes and also said the company did not have proper cleaning methods and systems.

In addition, the company did not have in process samples and controls. Its investigations into its facilities deficiencies also were of poor quality, FDA found.

Lupin responded this month that it would address the 483 observations and will soon fully comply with US FDA cGMP standards and keep the highest quality standards at all drug and API plants.

This is not the first time Tarapour has been criticized by the agency. In 2020, FDA stated that the facility had an OAI status, which means there were serious cGMP conditions found and regulatory actions would be taken.

Lupin has been criticized by FDA at other facilities in the past. In summer 2021, Novel Laboratories was given a long list of FDA violations, such as QC issues, poor cleaning and consistency, and more.

Given the similar problems at the Tarapour plant, parent company Lupin has been found by FDA to have inadequate corporate control and oversight over drug manufacturing. FDA also issued a warning letter to the company regarding its manufacturing operations and medications it produces at all sites.

Further, the company received an FDA warning letter in 2017 for violations at two Indian sites. This made Lupin say it would enhance quality compliance at all plants. Still, the company still received a warning letter and 483 for drug plants in Andhra Pradesh and Mandideep.

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