Furthermore, the team and I have secured a leading U.S. clinical site that has successfully passed FDA inspection. We are in the process of finalizing an LOI, and we'll be announcing the details ...

Amid concerns about FDA’s capacity to meet safety mandates following the departure of 3,500 employee since January, the ...

After a slowdown in FDA inspections during the first quarter of 2025 and the mass departure of over 3,500 employees, FDA ...

FDA inspections are essential to ensuring the safety and quality of products in the food, pharmaceutical, and medical device industries. One of the experienced professionals in this field is John ...

Zhong Li’s extensive history with the FDA offers crucial lessons on how companies in the pharmaceutical and biopharmaceutical sectors should approach inspection preparedness.  As an experienced FDA ...

The U.S. Food and Drug Administration (FDA) announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines ...

The FDA has said it plans to conduct more unannounced inspections at foreign facilities that produce food and medical products intended for Americans.

FDA conducts 12K domestic inspections yearly, but only 3K abroad—foreign sites flagged for serious issues over twice as often. Johnson & Johnson, Roche, and Novartis plan over $128 billion in ...

"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.

On May 6, 2025, the U.S. Food and Drug Administration (FDA ... to maintain the integrity of the inspection oversight process.” Of note, foreign facilities are subject to additional conditions ...

and for-hire vehicle transit), to maintain the integrity of the oversight process. The U.S. FDA conducts around 12,000 domestic inspections and 3,000 foreign inspections every year in more than 90 ...

WASHINGTON — For the second time in recent months, the Food and Drug Administration is bringing ... The same uncertainty hangs over employees who process agency records for release to lawyers ...