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Unichem Labs Ghaziabad facility successfully completes USFDA inspection


Unichem Labs Ghaziabad facility successfully completes USFDA inspection

The US Food and Drug Administration (USFDA) conducted an inspection of the company’s Ghaziabad facility from March 3-8, 2019, and it has been successfully concluded without any USFDA form 483 issued, Unichem Labs said in a BSE filing.

New Delhi: Headquartered in Mumbai, drug firm Unichem Laboratories Monday said the US health regulator has concluded inspection of its Ghaziabad facility without making any observations.

The US Food and Drug Administration (USFDA) conducted an inspection of the company’s Ghaziabad facility from March 3-8, 2019, and it has been successfully concluded without any USFDA form 483 issued, Unichem Laboratories said in a BSE filing.

Form 483 is issued by the USFDA to notify a company’s management of any objectionable condition at its manufacturing facility. The form is issued after completing the inspection.

The U.S. Food and Drug Administration (FDA) is authorized to perform inspections under the Federal Food, Drug, and Cosmetic Act, Sec. 704 (21 USC §374) “Factory Inspection”. Form FDA 483, “Inspectional Observations,” is a form used by the FDA to document and communicate concerns discovered during these inspections.



Source: PTI
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