Last Updated: February 20, 2023, 10:40 IST
On conclusion of the inspection, Cipla has received eight inspectional observations in Form 483. (Representational pic/AP)
Cipla will work closely with the USFDA and is committed to address these comprehensively within stipulated time
Shares of Cipla on Monday tanked nearly 7 per cent in morning trade on the bourses after the company said the US health regulator has issued ‘Form 483’ with eight observations after inspecting its Pithampur-based manufacturing facility in Madhya Pradesh.
The stock declined 6.78 per cent to Rs 956.20 on the BSE. At the NSE, it tanked 6.87 per cent to Rs 955.25.
The US Food and Drug Administration (USFDA) conducted a current Good Manufacturing Practices (cGMP) inspection at the manufacturing facility from February 6-17, the Mumbai-based drug firm said in a regulatory filing on Saturday.
On conclusion of the inspection, the company has received eight inspectional observations in Form 483, it added.
The company will work closely with the USFDA and is committed to address these comprehensively within stipulated time, it said.
As per USFDA, Form 483 is issued to a firm’s management at the conclusion of an inspection when the investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
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(This story has not been edited by News18 staff and is published from a syndicated news agency feed)
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