In this video interview, Luke Wilson, senior director, biotech, pharma services at Thermo Fisher Scientific, discusses how ...

"While U.S. manufacturers undergo frequent, unannounced inspections, foreign firms have often had weeks to prepare, undermining the integrity of the oversight process," the FDA continued.

Dexcom received FDA observations “related to process improvement and documentation requests,” the analysts said, and implemented process controls three months ago in response to the Form 483s.

Moon N Sea Ga Llc. issued a voluntary recall on June 24 for various fish products after they were potentially produced under ...

CBS News reported Thursday that the Food & Drug Administration (FDA) is preparing to end all of its routine food inspections, though how and when it plans to end it depends on Congress.

The presentation will cover important documents such as the Establishment Inspection Report, and the FDA Notice of Observations. The presentation will also cover the different steps the investigator ...

Further, as during the COVID-19 pandemic, FDA may default to remote inspections based on paper reviews, which creates new issues and challenges with respect to communication and information sharing.

Following responses of self-audit from around 800 manufacturers in the state, the Maharashtra Food and Drug Administration (FDA) has started risk-based inspections for an effective oversight on the ...

Dive Insight: FDA inspectors visited Dexcom’s facility in Mesa, Arizona, in June and its San Diego site in October and November.The inspections generated a Form 483 that listed observations the ...