On July 11, 2025, the U.S. Department of Health and Human Services (“HHS”), Office of Inspector General (“OIG”) posted a report that announced the findings of a cybersecurity audit it conducted of a large Northeastern...more
In their song, “Surprise, Surprise,” the Rolling Stones lamented about being caught off guard by a disappointing relationship. Sixty years later, foreign manufacturers may face the surprise of an unannounced inspection by the...more
5/23/2025
/ Compliance ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Imports ,
Inspection Rights ,
International Trade ,
Life Sciences ,
Manufacturers ,
New Regulations ,
Regulatory Requirements
Background - On March 21, 2025, the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) announced a settlement with Health Fitness Corporation (“Health Fitness”), a company that provides wellness...more