US FDA issues Form 483 with 1 observation after unannounced inspection of Satara plant

US FDA did an unannounced inspection of the Satara plant from 5 October 2026 to 9 October 2026.

Fri 9 Oct 2026

Inspection Period

5 October 2026 to 9 October 2026

Form 483 Observations

1 observation

Observation Nature

procedural and does not relate to data integrity

What the update says

• The United States Food and Drug Administration (US FDA) conducted an unannounced inspection of the company's manufacturing facility located at J4/2, Additional MIDC, Satara – 415 004, Maharashtra, India, from Monday, 5 October 2026 to Friday, 9 October 2026.
• Upon conclusion of the inspection, a Form 483 containing 1 observation was issued to the company.

What the company states about the observation

• The observation is procedural in nature and does not relate to data integrity.
• The company says it is confident of working closely with the regulator to successfully conclude the evaluation in a timely manner.

What the company adds about the site and other inspections

• A successful inspection outcome for the Satara facility would be the first successful unannounced inspection for this site.
• The previous inspection in January 2023 was the first ever US FDA inspection for the site, for which the company was provided prior intimation.
• Upon conclusion, this would be the third successful unannounced US FDA inspection for the company in FY2026-27, considering the inspections of its Toronto (Canada) R&D facility in April 2026 and its Pithampur (India) manufacturing facility in July 2026.
• The company's recently acquired manufacturing facility in East Brunswick, New Jersey, USA was inspected by the US FDA in May 2026, just prior to the company's acquisition of that facility in July 2026.

How a Form 483 fits in

• A Form 483 is the document the US FDA issues at the end of an inspection, setting out the observations it has made. The update mentions 1 observation for this inspection.
• The company has said it will keep the stock exchanges informed of any further updates on this subject.

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