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# FDA Highlights GMP Warning to Chinese OTC Drug Maker
- URL: https://www.fdaweb.com/fda-highlights-gmp-warning-to-chinese-otc-drug-maker/
- Published: 2019-08-20T12:00:00.000Z
- Updated: 2026-09-15T01:44:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144803

FDA is pointing to a new Warning Letter to a Chinese drug manufacturer as evidence of its increased “oversight of over-the-counter drug manufacturing and protecting consumers from products that may put them at risk.” The [Warning Letter](http://email.prnewswire.com/wf/click?upn=zySGXW1QLHU8t7wSbPI8iADmwAaKTbie2jeFmcdktocyFPZzEoI4ZXVkpLdpFaC-2BLqUfV7I-2BWoOWfuxlphXG9obzqtD6tNJ8y6cvg5gwQZQoXW-2BFF5WL8lr6-2Blcc0PsHxOxsKQjp0LJ9S8ir5j-2BVy6YFwD-2FjZEGtSK5iH97flU6s-2FnSQ5IhIkv-2BqQnZbSBcTDnnjGMd-2FkJWtNZV-2BiZ22j47TmMoNEssfdO1Pp3BaWheYxTab0TTG3YwZIhUSKVDU9Lbg7r30y4QCmEJP-2Bp-2B27ZVR78ifdT-2B4FIES9JcwI6ACRKM3lNJ89uzjSlUvQqsOucjBL7MOHrbE260vXVGKAw-3D-3D%5FnE9rxSXA5G4kxsTVkgv43tTJnmhvULg8vMtvbdZHwXEle6c6tqdvw12Z3skft0RuyICIKc2PZTGpEVR7Mmu-2BDoYw8bJM4wxG9kYm7hDTB2SeJOJTzWyp6I4OGkIebCjY0nVi5-2Bb4GMY5WPeM35oBHYySDJnGqGn-2FZAJGCywdT1Uhsbr-2FUtR3wTU3RDWCoaqjQRHd-2B8M3xwzhlKXqL-2FdRnbJWf8Vi27u-2BGrtVvfmNIUh2kQBhIw59ysiyKBvQVZjA4jERT-2FD9WK-2BtruexZnm92lkjwsU8bA19-2FSyOl81YWBGhLfr-2B3e7wy5CqKg-2Bnb7pOZ0TABB02XZ52g4ziZwCdYHbHlOFARAjcu8kNFL5e32Q-3D&ref=fdaweb.com) to Ningbo Huize Commodity cited GMP violations, including data integrity issues, associated with its sunscreens.

The letter details a “failure to have adequate quality control mechanisms in place,” according to an [FDA release](https://www.fda.gov/news-events/press-announcements/fda-warns-company-putting-consumers-risk-drug-manufacturing-data-integrity-violations?ref=fdaweb.com). “The company provided FDA investigators multiple documents that were falsified, including the cleaning validation reports and batch production and control records for multiple drugs. The firm also provided records showing they performed the required periodic reviews of their operation to assure quality, which they later admitted were also falsified. These CGMP violations cause all drugs manufactured by Ningbo Huize to be adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act).”

FDA’s release notes that a 2018 [guidance for industry](http://email.prnewswire.com/wf/click?upn=zySGXW1QLHU8t7wSbPI8iADmwAaKTbie2jeFmcdktocyFPZzEoI4ZXVkpLdpFaC-2BdrvfcGZ62hjZfTP-2BnfgDIFCzg7yx7mUaDa7b6r3MxB8rmlBe-2BQiANDPQEt6FH4CMRwRM3sICLm1d8JWtqMVjcwksU8jxk11lUFq1-2B034ab5bhPgN-2Fw9r-2FAiT5hzFIiHGXh0SYu4nlfWjrrUXOwAGT2Hj4l-2BLbYo7QQXtgP90-2Bu4rS8AQl-2FoD6b-2B12gejggBH5773QQswjCztwBKYyksZy5V9qYhTM6Hqjtw9UP8O4rsK01id2sFabREK4p8svUQ38uj0OC93NiRrvDicV742zg-3D-3D%5FnE9rxSXA5G4kxsTVkgv43tTJnmhvULg8vMtvbdZHwXEle6c6tqdvw12Z3skft0RuyICIKc2PZTGpEVR7Mmu-2BDoYw8bJM4wxG9kYm7hDTB2SeJOJTzWyp6I4OGkIebCjY0nVi5-2Bb4GMY5WPeM35oBHYySDJnGqGn-2FZAJGCywdT1Uhsbr-2FUtR3wTU3RDWCoaqjQRHd-2B8M3xwzhlKXqL-2FdRna4lfzzB4nzz38jDK5ZsspyfaB-2FFsULjfi0k9Fii4TKXysVq-2BcCuVHl8Qa5Pku8X1wWXCLxhuT-2Bv9coQbvlSilRZsYKxkMvZ4WmYEa6udkCCtpT5VMSEnm0w-2BrtUisQCdBR70l5CBNsyP5ZMbNoMx0w-3D&ref=fdaweb.com) updates its recommendation on ensuring data integrity and compliance with GMPs. “Pharmaceutical quality can only be assured by robust quality control, which includes vigilant oversight of data integrity,” it says.

Following the inspection in March, FDA says it placed the company on import alert in June to prevent their drugs from entering the U.S. The company has also agreed to recall its drugs.