Tag Archives: regulatory violation

OTC Personal Products Manufacturer Cited by FDA for Various Regulatory Violations

On August 20, 2019, the U.S. Food and Drug Administration announced that it had sent and posted a warning letter to an over-the-counter drug manufacturer citing “significant” violations of current good manufacturing practice (CGMP) and also issued a news release in connection with this letter. The letter was sent to NingBo Huize Commodity Co., Ltd., a China-based manufacturer of health and beauty products such as sunscreen lotion, shampoo, hand sanitizer and lip balm, following FDA’s inspection of the facility in March 2019. In particular, the warning letter, and concurrent press release and import alert, show that FDA continues to have significant concerns related to data integrity and will harshly sanction companies that falsify data.

View the full Alert on the Duane Morris LLP website.