FDA 483s on Indoco plant not related to data integrity issues

The US Food and Drug Administration has issues six Form 483s for Indoco Remedies's Goa plant II. The management however, has clarified that it may not be a major setback to the drug company as it is not related to data integrity.A FDA form 483 is issued to a company when the FDA finds any conditions that may be in violation to the Food Drug and Cosmetic (FD&C) Act and related Acts. US FDA inspected the Goa plant II for five days starting from August 31. Injectable Abbreviated New Drug Application (ANDA) filings had triggered the US FDA to inspect the plant.The observations in the 483s are not known for now, but they cause a push back in approval rates, especially when it comes to injectibles. This can lead to a ripple effect, with other drug regulatory authorities also becoming more stringent in their inspections and approvals.Watch video for more.,