New Delhi: Drug firm Cadila Healthcare on Thursday said the US health regulator has issued no observations after completion of inspection of its Moraiya plant in Gujarat.
The United States Food and Drug Administration (USFDA) has inspected the company’s Moraiya facility from August 31- September 7, 2017, Cadila Healthcare said in a statement.
“At the end of the inspection, no observation (483) is issued”, it added.
As per the US FDA, observations are made in Form 483 when investigators feel that conditions or practices in the facility are such that products may become adulterated or render injurious to health.
The FDA Form 483 notifies the company’s management of objectionable conditions.