New Delhi, Apr 18 (PTI) Marksans Pharma Ltd on Thursday said the US health regulator has issued a Form 483 with five inspectional observations after inspecting its manufacturing facility at Vema, in Goa.

The US Food and Drug Administration (USFDA) had conducted a routine current Good Manufacturing Practices (cGMP) inspection at the manufacturing facility from April 9-17, 2024, the company said in a regulatory filing.

Also Read | Lok Sabha Elections 2024 Phase 1: When Is Voting and Result? How To Vote, Check Name in Voter List? How To Find Polling Station? Know Everything Here.

"On conclusion of the inspection, the company has received five inspectional observations in Form 483," Marksans Pharma said.

As per US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Also Read | MHADA Maharashtra Lottery 2024: Know Eligibility Criteria, List of Required Documents and How To Apply Online at housing.mhada.gov.in.

There is no data integrity observation, it added.

The company will work closely with the USFDA and is committed to address these observations comprehensively within the stipulated time, the filing said.

(This is an unedited and auto-generated story from Syndicated News feed, LatestLY Staff may not have modified or edited the content body)