Foreign Firms’ Supplement GMP Problems Rival US Warnings
This article was originally published in The Tan Sheet
One firm was on FDA’s import alert due to supplement GMP problems at the end of 2014, but more firms in 2015 “have been demonstrated to be non-compliant … to the point that we want to prevent the products from entering the US market,” according to the agency
You may also be interested in...
FDA's "detention without physical examination" import alerts allows it to " detain affected [import] products if inspection has revealed that a firm is not operating in conformity with" GMPs, though it typically seeks to prevent distribution of a domestic firm's products only after it fails to respond to a warning letter.
Perrigo is latest consumer health firm to note substantially slower flu rates slammed OTC drug sales during 2020 fourth quarter. Its total cough/cold product sales for the year were off $63m on decreases of $34m in the Americas and $29m in its international markets.
In deal with Altaris Capital, “I don't feel like we got out at any cost,” says Perrigo CEO Murray Kessler. Agreement calls for “a number of mutual long-term relationship components ... including on Rx-to-OTC switches."