Dr Reddy's Laboratories has received a Form 483 with seven observations from the US Food and Drug Administration (USFDA) for its formulations manufacturing facility in Srikakulam, Andhra Pradesh.

The Hyderabad-based pharmaceutical company disclosed the development in a regulatory filing, reported PTI on Sunday. The USFDA carried out both a Good Manufacturing Practices (GMP) inspection and a Pre-Approval Inspection (PAI) at the site from July 10 to 18.

“We have been issued a Form 483 with seven observations, which we will address within the stipulated timeline,” the company said.

A Form 483 is issued at the conclusion of an inspection when USFDA investigators observe conditions that may be in violation of the Food, Drug and Cosmetic (FD&C) Act.

It serves as an alert for the company’s management and requires a detailed response, usually within 15 working days, explaining corrective measures.

Dr Reddy’s shares ended 0.4 per cent lower on the day the disclosure was made.

The Srikakulam plant plays a critical role in supplying formulations for global markets, making the inspection outcome relevant.

But this isn’t the first time the company’s Srikakulam operations have drawn scrutiny.

In June 2024, the API plant at the same location received a Form 483 with four observations after a GMP inspection by the USFDA. The company committed to addressing the issues within the required timeframe.

The regulator later classified the outcome as “Voluntary Action Indicated” (VAI), meaning no immediate enforcement action was necessary, although improvements were expected.

In July 2022, following a week-long inspection at the same site, Dr Reddy’s received two Form 483 observations after a pre-approval check. As before, the company stated it would respond within the timeline set by the USFDA.

In 2017, a Form 483 was issued with either one or two observations at the same Srikakulam API manufacturing facility, reports vary on the count. The concerns focused on laboratory data integrity and potential data manipulation.

Inspectors noted documentation delays and incomplete responses.

Company officials reportedly argued the issues were not severe, but the USFDA disagreed, citing risks linked to incomplete validations and data integrity.

The 2017 inspection placed the plant under extended regulatory oversight. The USFDA classified the site as “Official Action Indicated” (OAI), which remained in place until the company implemented the necessary changes.

As of now, Dr Reddy’s has not disclosed the nature of the seven observations from the latest inspection.