PharmaTech Recalls Highlight Supplement GMP Diligence For Marketers – CRN
This article was originally published in The Rose Sheet
PharmaTech customers recall liquid supplements, including products indicated for children, after CDC informs FDA that an antibiotic-resistant pathogen was found in a PharmaTech Rx drug. CRN says the recall should remind supplement firms about tracking supply chains and auditing contract manufacturers.
You may also be interested in...
Firm’s problems “illustrate just how important it is for senior managers to prioritize manufacturing quality, to prioritize patient safety and prevent the absolutely tragic consequences that resulted here,” says Don Ashley, CDER compliance office director.
FDA Office of Criminal Investigations says Raidel Figueroa, former co-owner of Pharmatech in Broward County, is charged with as conspiracy “to manufacture and distribute drugs outside the regulatory oversight of the FDA, to interfere with and obstruct the FDA” in its investigation of Pharmatech’s manufacturing of an OTC monograph constipation treatment.
Supplements spiked with ED drugs recalled; Agritek Holdings purchases nutrition and supplement marketer Performance Nutrition Center; more dietary supplement recalls and other news in brief.