Aurobindo Gets Hit With Another Form 483

Aurobindo Gets Hit With Another Form 483

Aurobindo Pharma has taken another hit from the FDA after an inspection of its oral drug manufacturing facility in Hyderabad, India, earlier this month resulted in a Form 483 report with six observations.

The company did not give details of the inspection observations, but it has a history of quality problems observed during previous FDA inspections of the facility.

Just four months ago, the agency issued a warning letter for the Hyderabad plant following an agency inspection that took place in August 2021. The letter, issued on Jan. 12, cited the company for significant deviations from current good manufacturing practices for active pharmaceutical ingredients.

In September 2019, Aurobindo received a seven-observation Form 483 following an inspection of a different facility in Telangana.

The company said it will work with the FDA to deal with the deficiencies noted in the latest inspection.

May 13, 2022

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