Rise in FDA Violations Linked to Raw Material Testing of High-Risk Drug Components

The recent spike in FDA warning letters citing violations of 21 CFR 211.84, which mandates testing of starting materials and excipients, is largely linked to updated regulatory focus on high-risk ingredients. In 2023, the FDA issued guidance on testing glycerine, propylene glycol, sorbitol, and other components for contamination with ethylene glycol (EG) and diethylene glycol (DEG) following fatal incidents in paediatric medicines reported by WHO in Gambia, Indonesia, and Uzbekistan.

DEG and EG are toxic industrial chemicals sometimes fraudulently substituted for glycerine due to cost, a problem dating back to the 1937 sulfanilamide tragedy. Recurring lapses include missing identity and purity tests, blind reliance on supplier certificates, and falsified manufacturer information.

Warning letters from 2023–25 also highlight ethanol contamination in sanitizers and topical products, a trend exacerbated by the pandemic as new manufacturers entered the market without adequate testing. These FDA guidelines reinforce Section 211.84 and are critical for protecting consumers from lethal adulterants.

14-01-2026