Topic: quality control

China facility of Ausmetics hit with FDA warning letter

The FDA has banned products from an Australian company's plant in Guangzhou, China, and cited it with “significant violations” of cGMP regulations saying that it did not do enough to test its active ingredients and products before they were shipped to the U.S.
FDA sign

India's Indoco acknowledges Form 483

Indoco Remedies is the latest Indian drugmaker to run into issues with the FDA, having received a Form 483 with a half-dozen observations during a preapproval plant inspection.