Company News, Regulations

New FDA Warning Letters

US-based contract testing lab and an OTC/cosmetics producer in India flagged by agency.

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By: Christine Esposito

Editor-in-Chief

The FDA has issued warning letters to a US-based contract testing lab and an OTC/cosmetics producer in India. Advanced Botanical Consulting and Testing Inc., Tustin, CA, was sent a letter following an FDA inspection in November 2018 in which the agency found “significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211” and the company responded on Dec. 4, 2018.  According to FDA, during its inspection, an inve...

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