Company Cited For Not Testing Known Contaminants
All dietary ingredients must be tested for identity
Testing for known contaminants is an essential part of GMPs. This company was cited for not conducting proper identification and known contaminant testing on glycerin, an ingredient used in its manufacturing.
The known contaminant in glycerin is diethylene glycol (DEG). During one GMP inspection I helped oversee, FDA was happy to see we had tested for DEG in glycerin. This showed we were aware of the potential safety issue with glycerin and were taking steps to ensure the finished product was safe.
Learn more with the FDA’s guidance document, Testing of Glycerin for Diethylene Glycol.
Other known contaminants are melamine in milk and methanol in ethanol. What other known contaminants does your company test for?
The company that received this letter is an OTC and homeopathic drug manufacturer, but supplement folks can learn from this. Also, FDA cited the company for not proving their method was sufficient to test for DEG. As I discussed last week, proving test method suitability is top of mind for FDA investigators.
Read the full letter here.
Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.