Stride Shasun’s South Bengaluru Plant Receives Three Observations From USFDA


Strides Shasun, an Indian pharmaceutical company has received three observations for its South Bengaluru plant from the United States Food & Drugs Administration (USFDA).

The U.S. Food and Drug Administration (FDA) is authorised to perform inspections and form 483 is a form used by the USFDA to document and communicate concerns discovered during these inspections.

A recipient of a form 483 should respond to the USFDA, addressing each item, indicating agreement and either providing a timeline for correction or requesting clarification of what the USFDA requires.

The stock of the company was losing ground on the NSE and was trading at Rs 936 per share lower by Rs 20 per share or 2.1% at 1035 hours.

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