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

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 ...

BOSTON, May 29, 2025 /PRNewswire/ -- On May 20, Medicilon Preclinical Research (Shanghai) LLC ("Medicilon") announces that it has successfully passed an on-site inspection by the FDA. The company ...

The FDA has made additional reports on inspections of ByHeart infant formula plants available. The company’s formula has been determined to be the source of at least 37 cases of infant botulism. The ...

Univo IRB, today’s fastest-growing central institutional review board (IRB), announced it has successfully completed a ...

After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...

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

Capricor Therapeutics announced that it has successfully completed the U.S. FDA's Pre-License Inspection of its San Diego manufacturing facility for its lead therapy candidate, Deramiocel, aimed at ...

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 ...

Freedom of Information Act requests filed with the Food and Drug Administration by hedge funds last month revealed big financial players closely eyeing warning letters, enforcement documents, and ...