Granules India Limited on Friday said the US Food and Drug Administration (USFDA) has concluded a current Good Manufacturing Practice (cGMP) inspection of its finished dosage facility at Gagillapur, Hyderabad, with the issuance of a Form FDA 483 containing 11 observations.
The inspection was conducted between October 19 and October 30, 2026. This was the first USFDA inspection of the facility since the Warning Letter issued on February 26, 2025, following an inspection in August-September 2024.
The company said none of the observations were related to data integrity or cross-contamination. The observations relate to enhancements in investigations, change control, process and equipment qualification, visual-inspection controls and documentation practices.
Granules India said there is no impact on manufacturing or distribution of products from the facility. The company will submit a comprehensive response to the USFDA within the stipulated 15 business days.
Commenting on the inspection, Chairman and Managing Director Dr. Krishna Prasad Chigurupati said the observations were of a nature that the company believes can be addressed through its responses and corrective and preventive actions.
In a separate development, the firm said on October 2 that it has incorporated a wholly owned foreign subsidiary, Triton Farmaceutica Do Brasil Ltda, in Brazil.
The newly incorporated entity will operate in the pharmaceuticals industry and has not yet started its business, according to the company.
Granules India said the subsidiary has been incorporated to manufacture, promote, sell and distribute pharmaceuticals and other related products in Brazil.
Upon incorporation, Triton Farmaceutica Do Brasil Ltda became a related party to Granules India. However, the company’s promoter and promoter group do not have any interest in the newly incorporated entity, the filing said.
The incorporation requires prior approval of the Reserve Bank of India under the automatic route, according to the company.
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