FDA Foreign Inspections Capture Monograph, GMP Violations
This article was originally published in The Tan Sheet
Executive Summary
An August letter to Jabones Pardo follows a number of FDA warnings to international firms that market products in the cosmetics and personal care space and violate U.S. drug regulations. Warnings to OTC product firms outside the U.S. over the past two years reflect the higher priority FDA has assigned to inspecting international firms.
You may also be interested in...
FDA Enforcement Priorities Include Globalization Threats
FDA will overhaul its enforcement approach to reflect the impact of globalization by partnering more with foreign counterparts, streamlining inspections, recalls and emergency responses and using stiff criminal sanctions to deter noncompliance, agency officials say.
Jurors' Answers In FTC Complaint Against Prevagen Might Form A Memory Bubble For Health Claims
“No” answers in New York federal court on whether all but two of Prevagen claims were “materially misleading” could put a fork in the road of a long dispute between FTC and supplement product manufacturers and marketers.
MLM Group Not Buying FTC Executive’s Concerns About Its Income Disclosure Guidance
FTC Division of Marketing Practices assistant director concerned direct selling self-regulation group’s guidance “will encourage deceptive conduct and facilitate deceptive earnings claims.” DSA president says the concerns might reflect the thinking of agency’s staff more than the intent of the agency’s regulations.