On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a plan to expand its use of unannounced inspections of foreign manufacturing facilities that produce foods, essential medicines ...

We’ve launched a first-of-its-kind app to help you find out where your generic drugs come from and see the track records of ...

The repeat problems at Houston-based Empower Pharmacy include inadequate quality testing and a failure to clean equipment.

Industry consultant Michael Drues will discuss how medical device companies can better prepare for FDA inspections.

The Food and Drug Administration is developing a plan to shift more food safety inspection responsibility to state agencies over the course of five years, according to two sources familiar with ...

FDA officials reviewed the company’s internal processes, technology platforms, data integrity measures, patient safety protocols, and documentation during the inspection. This marks Science 37’s third ...

MedPharm’s topical drug product manufacturing facility in Durham has successfully completed an FDA inspection for commercial manufacture of drug products.

ProPublica is a Pulitzer Prize-winning investigative newsroom. Sign up for The Big Story newsletter to receive stories like this one in your inbox. U.S. inspectors have uncovered new and dangerous ...

Investing.com -- Capricor Therapeutics Inc (NASDAQ: CAPR) stock tumbled 10.5% after the company announced that the FDA’s inspection of its San Diego manufacturing facility resulted in a Form 483 with ...

Dublin, Sept. 23, 2025 (GLOBE NEWSWIRE) -- The "FDA Inspection Preparedness and Compliance (Dec 2nd-3rd, 2025)" has been added to ResearchAndMarkets.com's offering. This is a practical, hands-on ...

The U.S. Food and Drug Administration (FDA) recently issued final guidance entitled “Conducting Remote Regulatory Assessments,” which explains the agency's plans to continue utilizing its records ...