USFDA completes inspection of Unichem Lab’s Roha facility with no observation

The US health regulator conducted inspection at the company's active pharmaceutical ingredients (APls) manufacturing unit at Roha from 17th to 21st February, 2020
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Drug firm Unichem Laboratories recently said that the United States Food and Drug Administration (USFDA) has completed inspection of its Roha facility in Maharashtra without any observation.

The US health regulator conducted inspection at the company’s active pharmaceutical ingredients (APls) manufacturing unit at Roha from 17th to 21st February, 2020, Unichem Laboratories said in a BSE filing.

“The inspection was a routine cGMP surveillance and successfully concluded without any FDA form 483 issued,” it added.

As per the USFDA, Form 483 is issued to firm management at the conclusion of an inspection when investigators have observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic Act and related Acts.

APIsRohaUnichem LabUSFDA
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