News & Analysis as of

Manufacturers Inspection Rights

Arnall Golden Gregory LLP

Surprise, Surprise: FDA Announces Plans to Increase Number of Unannounced Inspections at Foreign Manufacturing Facilities

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

Robinson+Cole Manufacturing Law Blog

2020 Environmental, Health & Safety Outlook for Manufacturers

Welcome to 2020! As always, we at the Manufacturing Law Blog are starting the year with our annual forecasts of hot topics....more

Seyfarth Shaw LLP

OSHA Updates National Emphasis Program on Amputations in Manufacturing Industries

Seyfarth Shaw LLP on

Seyfarth Synopsis: OSHA recently updated its National Emphasis Program on Amputations in Manufacturing Industries (NEP), adding a targeting methodology for industries with high employer-reported amputation statistics....more

Hogan Lovells

FDA Finalizes Data Integrity Guidance, With Some Noteworthy Changes

Hogan Lovells on

Earlier yesterday, FDA published the final guidance “Data Integrity and Compliance With Drug CGMP: Questions and Answers,” which updates April 2016 draft guidance that covers the design, operation, and monitoring of systems...more

Hogan Lovells

FDA publishes internal policy on prioritizing surveillance inspections for drug manufacturing sites

Hogan Lovells on

Earlier yesterday, FDA Commissioner Scott Gottlieb, M.D., made publicly available for the first time FDA’s internal policy (MAPP 5014.1) for how drug manufacturing facilities are prioritized and scheduled for surveillance...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update | September 2017

Shook Partners Lindsey Heinz and Katie Gates Calderon, with Associate Hillary Nicholas, have authored an article for Law360 discussing regulations related to the use of photography during a U.S. Food and Drug Administration...more

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