FDA issues warning letters to several companies in February

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In the first half of February, the FDA issued several warning letters to companies and facilities for violations of cGMP regulations. The agency’s Center for Drug Evaluation and Research and Division of Pharmaceutical Quality Operations divisions sent warning letters to two hand sanitizer companies, a Turkish drug manufacturer, a Palm Beach Fertility Center and a dietary supplement facility. The FDA says that if these companies don’t follow the regulations specified in the warning letters, they could face regulatory or legal action.

Warning letter to Clean Cosmetics over cGMP violations

Clean Cosmetics received a warning letter from the FDA for not complying with cGMP regulations for hand sanitizer. The FDA found that they didn’t test the components of their drug products, had inadequate laboratory controls and didn’t comply with quality controls for dru…

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