08.21.19
The US FDA has sent a warning letter to Wenxuan Han, general manager/owner of NingBo Huize Commodity Co., Ltd., a Chinese company, following an inspection of its drug manufacturing facility in March 2019 where it found violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, specifically sunscreen products.
FDA said that the firm's methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, which makes its drug products adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B), said FDA.
NingBo Huize Commodity manufactures “SPF 30 Sunscreen Lotion” 30mL and “SPF 30 Sunscreen Lotion” 60mL that are misbranded drug products. Specifically, “SPF 30 Sunscreen Lotion” 30mL is misbranded under sections 502(f)(1) and (f)(2) of the FD&C Act, 21 U.S.C. 352(f)(1) and (f)(2). Additionally, “SPF 30 Sunscreen Lotion” 60mL is misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). Introduction of such products into interstate commerce is prohibited under sections 301(a) of the FD&C Act, 21 U.S.C. 331(a).
During its inspection, an FDA investigator observed specific violations including, but not limited to, CGMP violtions and misbranded products.
According to FDA,the firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22 (a)).
During inspection, the company’s quality staff provided multiple quality documents to our investigator. Based on concerns with the documents provided, the FDA investigator questioned the company’s quality manager regarding the validity of these documents, who stated that multiple documents provided were in fact falsified “for the purpose of this inspection.”
Falsified documents include cleaning validation reports, batch records for multiple drug products, and annual product reviews. Furthermore, you also stated that you could not provide basic records to support the CGMP requirements for the manufacture of drugs, including, but not limited to, the following:
FDA said the company’s response is inadequate because it failed to fully review the scope of your deficiencies, and provide evidence that you have comprehensively remediated systems, and to implement procedures and programs that ensure ongoing control over drug manufacturing operation.
FDA asked NingBo Huize Commodity Co., Ltd to provide:acomprehensive assessment and remediation plan to ensure the quality unit (QU) is given the authority and resources to effectively function; a comprehensive, independent assessment of the overall system for investigating deviations, discrepancies, complaints, out-of-specification (OOS) results, and failures, including a detailed corrective action and preventive action (CAPA) plan to remediate this system; a comprehensive, independent review of the material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates; a complete, independent assessment of documentation systems used throughout the manufacturing and laboratory operations to determine where documentation practices are insufficientl; and a full summary of data integrity assessments performed by a third-party consultant.
FDA also indicated misbranded drug violations related to sunscreen products. Among the issues were the label’s failure to include all of the required warnings described under 21 CFR 201.327(d) and all applicable directions for use as required under 21 CFR 201.327(e).
FDA said it placed the firm on Import Alert 66-40 on June 13, 2019.
FDA said that the firm's methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, which makes its drug products adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B), said FDA.
NingBo Huize Commodity manufactures “SPF 30 Sunscreen Lotion” 30mL and “SPF 30 Sunscreen Lotion” 60mL that are misbranded drug products. Specifically, “SPF 30 Sunscreen Lotion” 30mL is misbranded under sections 502(f)(1) and (f)(2) of the FD&C Act, 21 U.S.C. 352(f)(1) and (f)(2). Additionally, “SPF 30 Sunscreen Lotion” 60mL is misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). Introduction of such products into interstate commerce is prohibited under sections 301(a) of the FD&C Act, 21 U.S.C. 331(a).
During its inspection, an FDA investigator observed specific violations including, but not limited to, CGMP violtions and misbranded products.
According to FDA,the firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22 (a)).
During inspection, the company’s quality staff provided multiple quality documents to our investigator. Based on concerns with the documents provided, the FDA investigator questioned the company’s quality manager regarding the validity of these documents, who stated that multiple documents provided were in fact falsified “for the purpose of this inspection.”
Falsified documents include cleaning validation reports, batch records for multiple drug products, and annual product reviews. Furthermore, you also stated that you could not provide basic records to support the CGMP requirements for the manufacture of drugs, including, but not limited to, the following:
- equipment qualification (21 CFR 211.63);
- raw material qualification and active pharmaceutical ingredient testing (21 CFR 211.84);
- finished product and raw material testing qualification (21 CFR 211.165);
- drug product stability program (21 CFR 211.166);
- batch records (21 CFR 211.188); and
- process validation (21 CFR 211.100).
FDA said the company’s response is inadequate because it failed to fully review the scope of your deficiencies, and provide evidence that you have comprehensively remediated systems, and to implement procedures and programs that ensure ongoing control over drug manufacturing operation.
FDA asked NingBo Huize Commodity Co., Ltd to provide:acomprehensive assessment and remediation plan to ensure the quality unit (QU) is given the authority and resources to effectively function; a comprehensive, independent assessment of the overall system for investigating deviations, discrepancies, complaints, out-of-specification (OOS) results, and failures, including a detailed corrective action and preventive action (CAPA) plan to remediate this system; a comprehensive, independent review of the material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates; a complete, independent assessment of documentation systems used throughout the manufacturing and laboratory operations to determine where documentation practices are insufficientl; and a full summary of data integrity assessments performed by a third-party consultant.
FDA also indicated misbranded drug violations related to sunscreen products. Among the issues were the label’s failure to include all of the required warnings described under 21 CFR 201.327(d) and all applicable directions for use as required under 21 CFR 201.327(e).
FDA said it placed the firm on Import Alert 66-40 on June 13, 2019.
