Happi Staff12.31.20
The US Food and Drug Administration (FDA) has sent a warning letter to Clientele, Inc., Sunrise, FL, for significant violations of current good manufacturing practiceregulations for finished pharmaceuticals, including products that it said provided sun protection.
The letter follows an inspection of the company’s facility on February 3-7, 2020.
FDA said the company’s methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are 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).
The company manufactures the over-the-counter (OTC) drug products including Age Blocker and Estro-Lift Day Therapy, which are misbranded under section 502(c) of the FD&C Act, 21 U.S.C. 352(c). In addition, Age Blocker is further misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), said FDA.
FDA said it acknowledged receipt of Clientele’s July 2, 2020 correspondence. However, it said the company did not provide specific information or evidence of corrective actions to the observations identified during the inspection. During the inspection, FDA said the company told the investigator that it would stop making drug products and plan to outsource the manufacture of your drug products to a third-party facility moving forward. In the company's July 2 correspondence, the firm mentioned that it engaged the services of a consultant with expertise in both cosmetic FDA regulations and GMP requirements.
The CGMP violations cited by FDA include:
Failure to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and (d)).
FDA said Clientele’s quality unit (QU) did not provide adequate oversight for the manufacture of your OTC drug products. For example, the firm's QU failed to ensure the microbiological testing was performed and reviewed for each batch before release; ongoing stability program was established; suppliers were adequately qualified; out-of-specification (OOS) results were thoroughly investigated and written procedures were established for investigations; and, annual product reviews were performed.
FDA said the ccompany also firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).
FDA also said it failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).
FDA further said the firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug product and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).
Regarding misbranding violations, FDA said that Age Blocker and Estro-Lift Day Therapy are drugs because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or as defined by section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body. Specifically, “Age Blocker” and “Estro-Lift Day Therapy” are intended for use as sunscreen drug products.
Examples of claims observed on the products’ labels that provide evidence of their intended uses (as defined by 21 CFR 201.128) include:
• “Age Blocker” Label Claims— “Helps Prevent Sunburn . . . Sunscreen SPF 30 . . . Anti-Aging Moisturizer and Sunblock in One”
• “Estro-Lift Day Therapy” Label Claims—“Helps Prevent Sunburn . . . Sunscreen SPF 30”
The labeling for such drugs does not comply with all of the requirements of section 502 of the FD&C Act and all pertinent regulations found in Title 21 of the Code of Federal Regulations, said FDA. Specifically, the products’ labels fail to include the statement, “[bullet] protect the product in this container from excessive heat and direct sun” under the header “Other information,” as required by 21 CFR 201.327(f), said FDA.
Age Blocker is further misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), said FDA which noted that the label states, “Anti-Aging Moisturizer and Sunblock in One.” According to 21 CFR 201.327(g), the claim “sunblock” is a false and/or misleading claim that renders the product misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).
According to FDA, the company committed in a statement provided to the investigator to cease manufacturing drug products and to deregister your facility as a drug manufacturer. If you plan to resume manufacturing or distributing drugs manufactured on your behalf by a contract manufacturer, notify this office before resuming your operations
FDA said that the firm stated that it would outsource the production of your OTC drugs to a third-party facility in the future. FDA asked the company to provide information regarding the selection of the contract manufacturer.
The letter follows an inspection of the company’s facility on February 3-7, 2020.
FDA said the company’s methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are 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).
The company manufactures the over-the-counter (OTC) drug products including Age Blocker and Estro-Lift Day Therapy, which are misbranded under section 502(c) of the FD&C Act, 21 U.S.C. 352(c). In addition, Age Blocker is further misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), said FDA.
FDA said it acknowledged receipt of Clientele’s July 2, 2020 correspondence. However, it said the company did not provide specific information or evidence of corrective actions to the observations identified during the inspection. During the inspection, FDA said the company told the investigator that it would stop making drug products and plan to outsource the manufacture of your drug products to a third-party facility moving forward. In the company's July 2 correspondence, the firm mentioned that it engaged the services of a consultant with expertise in both cosmetic FDA regulations and GMP requirements.
The CGMP violations cited by FDA include:
Failure to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and (d)).
FDA said Clientele’s quality unit (QU) did not provide adequate oversight for the manufacture of your OTC drug products. For example, the firm's QU failed to ensure the microbiological testing was performed and reviewed for each batch before release; ongoing stability program was established; suppliers were adequately qualified; out-of-specification (OOS) results were thoroughly investigated and written procedures were established for investigations; and, annual product reviews were performed.
FDA said the ccompany also firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).
FDA also said it failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).
FDA further said the firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug product and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).
Regarding misbranding violations, FDA said that Age Blocker and Estro-Lift Day Therapy are drugs because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or as defined by section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body. Specifically, “Age Blocker” and “Estro-Lift Day Therapy” are intended for use as sunscreen drug products.
Examples of claims observed on the products’ labels that provide evidence of their intended uses (as defined by 21 CFR 201.128) include:
• “Age Blocker” Label Claims— “Helps Prevent Sunburn . . . Sunscreen SPF 30 . . . Anti-Aging Moisturizer and Sunblock in One”
• “Estro-Lift Day Therapy” Label Claims—“Helps Prevent Sunburn . . . Sunscreen SPF 30”
The labeling for such drugs does not comply with all of the requirements of section 502 of the FD&C Act and all pertinent regulations found in Title 21 of the Code of Federal Regulations, said FDA. Specifically, the products’ labels fail to include the statement, “[bullet] protect the product in this container from excessive heat and direct sun” under the header “Other information,” as required by 21 CFR 201.327(f), said FDA.
Age Blocker is further misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), said FDA which noted that the label states, “Anti-Aging Moisturizer and Sunblock in One.” According to 21 CFR 201.327(g), the claim “sunblock” is a false and/or misleading claim that renders the product misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).
According to FDA, the company committed in a statement provided to the investigator to cease manufacturing drug products and to deregister your facility as a drug manufacturer. If you plan to resume manufacturing or distributing drugs manufactured on your behalf by a contract manufacturer, notify this office before resuming your operations
FDA said that the firm stated that it would outsource the production of your OTC drugs to a third-party facility in the future. FDA asked the company to provide information regarding the selection of the contract manufacturer.
