FDA WARNING_LETTER - NingBo Huize Commodity Co., Ltd. - March 22, 2019

The FDA inspected NingBo Huize Commodity Co., Ltd. from March 18-22, 2019, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). The firm manufactures "SPF 30 SUNSCREEN LOTION" (30mL and 60mL), which are also misbranded under 21 U.S.C. 352(f)(1) and (f)(2) due to inadequate labeling.

Key violations include the firm's failure to establish an adequate quality control unit (21 CFR 211.22(a)). During the inspection, the company's General Manager and Quality Manager admitted to falsifying multiple documents, including cleaning validation reports, batch records, and annual product reviews, "for the purpose of this inspection." They also could not provide basic CGMP records. The FDA deemed the firm's April 10, 2019, response inadequate due to the falsification history and insufficient remediation plans.

The FDA strongly recommended engaging a qualified consultant (21 CFR 211.34) to audit operations, evaluate corrective actions, and certify remediated quality systems and document validity. The firm's quality and data integrity systems are inadequate. Required actions include a comprehensive review of all data, a risk assessment, and a