Happi Staff01.23.20
The US Food and Drug Administration (FDA) has sent warning letter to a pair of companies Tismor Health and Wellness Pty Limited in Australia and CGA Limited in Trinidad & Tobago— related to their manufacturing processes, new drug claims and ingredients of an OTC antiseptic cream and a germicidal soap formulation.
FDA’s letter to Tismor Health and Wellness Pty Limited in Australia cited significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, including its product, Thursday Plantation Tea Tree Antiseptic Cream. According to FDA, this product is an unapproved new drug andintroduction or delivery for introduction of such products into interstate commerce is prohibited.
During FDA’s inspection, investigators observed specific violations including the following failure to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records. Further, FDA said the firm failed to establish written procedures for production and process control designed to assure that the drug products it manufactures have the identity, strength, quality, and purity they purport or are represented to possess and also failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, drug products conform to appropriate standards of identity, strength, quality, and purity.
FDA noted that Thursday Plantation Tea Tree Antiseptic Cream is a drug as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B. According to FDA, the formulation and labeling for the cream are not consistent with the conditions proposed in the OTC Topical Antimicrobial Products TFM nor with the TFM for OTC External Analgesic Drug Products. Specifically, Thursday Plantation Tea Tree Antiseptic Cream’s active ingredient, melaleuca alternifolia (tea tree) Leaf Oil 5%, is not a proposed active ingredient in either TFM, noted FDA.
FDA said it is not aware of any adequate and well controlled clinical trials in the published literature that support a determination that Thursday Plantation Tea Tree Antiseptic Cream is generally recognized as safe and effective for its labeled indications. Additionally, FDA said it was are not aware of a similar OTC product as formulated and labeled that was available in the United States market on or before the inception of the OTC Drug Review.
According to FDA, Thursday Plantation Tea Tree Antiseptic Cream, as formulated and labeled, is therefore a new drug within the meaning of section 201(p) of the FD&C Act because it is not generally recognized among scientific experts as safe and effective for the drug uses described in its labeling. FDA said “’new drugs’ may not be introduced or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FD&C Act is in effect for the drug.” FDA noted that the “antispectic cream is not the subject of an approved new drug application; therefore, the introduction or delivery for introduction of this product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d) and violates section 505 of the FD&C Act.
Similar situations were also cited at CGA Limited following FDA’s inspection of the company’s drug manufacturing facility last summer. FDA said it found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, including its CARIB Germicidal Soap.
During the inspection, FDA investigator observed specific violations including failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. CGA Limited also failed to validate and establish the reliability of its component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and (2)). The firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).
Also, FDA noted that CGA Limited released its topical over-the-counter (OTC) drug product to the US market although it COAs lacked critical tests including but not limited to the active ingredient assay and identity testing. In addition, the FDA said the firm lacked stability data to demonstrate that the properties of your drug product remain acceptable throughout its assigned shelf-life.
The agency said CGA Limited also failed to establish and follow adequate written procedures for cleaning and maintenance of equipment and failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.
The agency also reported an unapproved new drug charge for CARIB Germicidal Soap; the agency said that it is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that “CARIB Germicidal Soap” is generally recognized as safe and effective for its labeled indications. Additionally, we are not aware of a similar OTC product as formulated and labeled that was available in the United States market on or before the inception of the OTC Drug Review.
According to FDA, CARIB Germicidal Soap, as labeled, is therefore a new drug within the meaning of section 201(p) of the FD&C Act because it is not generally recognized among scientific experts as safe and effective for the drug uses described in its labeling. FDA also noted that “’new drugs’ may not be introduced or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FD&C Act is in effect for the drug. Further, FDA noted that CARIB Germicidal Soap is not the subject of an approved new drug application; therefore, the introduction or delivery for introduction of this product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d), and violates section 505 of the FD&C Act.
More information on both warning letters can be found here.
FDA’s letter to Tismor Health and Wellness Pty Limited in Australia cited significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, including its product, Thursday Plantation Tea Tree Antiseptic Cream. According to FDA, this product is an unapproved new drug andintroduction or delivery for introduction of such products into interstate commerce is prohibited.
During FDA’s inspection, investigators observed specific violations including the following failure to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records. Further, FDA said the firm failed to establish written procedures for production and process control designed to assure that the drug products it manufactures have the identity, strength, quality, and purity they purport or are represented to possess and also failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, drug products conform to appropriate standards of identity, strength, quality, and purity.
FDA noted that Thursday Plantation Tea Tree Antiseptic Cream is a drug as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B. According to FDA, the formulation and labeling for the cream are not consistent with the conditions proposed in the OTC Topical Antimicrobial Products TFM nor with the TFM for OTC External Analgesic Drug Products. Specifically, Thursday Plantation Tea Tree Antiseptic Cream’s active ingredient, melaleuca alternifolia (tea tree) Leaf Oil 5%, is not a proposed active ingredient in either TFM, noted FDA.
FDA said it is not aware of any adequate and well controlled clinical trials in the published literature that support a determination that Thursday Plantation Tea Tree Antiseptic Cream is generally recognized as safe and effective for its labeled indications. Additionally, FDA said it was are not aware of a similar OTC product as formulated and labeled that was available in the United States market on or before the inception of the OTC Drug Review.
According to FDA, Thursday Plantation Tea Tree Antiseptic Cream, as formulated and labeled, is therefore a new drug within the meaning of section 201(p) of the FD&C Act because it is not generally recognized among scientific experts as safe and effective for the drug uses described in its labeling. FDA said “’new drugs’ may not be introduced or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FD&C Act is in effect for the drug.” FDA noted that the “antispectic cream is not the subject of an approved new drug application; therefore, the introduction or delivery for introduction of this product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d) and violates section 505 of the FD&C Act.
Similar situations were also cited at CGA Limited following FDA’s inspection of the company’s drug manufacturing facility last summer. FDA said it found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, including its CARIB Germicidal Soap.
During the inspection, FDA investigator observed specific violations including failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. CGA Limited also failed to validate and establish the reliability of its component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and (2)). The firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).
Also, FDA noted that CGA Limited released its topical over-the-counter (OTC) drug product to the US market although it COAs lacked critical tests including but not limited to the active ingredient assay and identity testing. In addition, the FDA said the firm lacked stability data to demonstrate that the properties of your drug product remain acceptable throughout its assigned shelf-life.
The agency said CGA Limited also failed to establish and follow adequate written procedures for cleaning and maintenance of equipment and failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.
The agency also reported an unapproved new drug charge for CARIB Germicidal Soap; the agency said that it is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that “CARIB Germicidal Soap” is generally recognized as safe and effective for its labeled indications. Additionally, we are not aware of a similar OTC product as formulated and labeled that was available in the United States market on or before the inception of the OTC Drug Review.
According to FDA, CARIB Germicidal Soap, as labeled, is therefore a new drug within the meaning of section 201(p) of the FD&C Act because it is not generally recognized among scientific experts as safe and effective for the drug uses described in its labeling. FDA also noted that “’new drugs’ may not be introduced or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FD&C Act is in effect for the drug. Further, FDA noted that CARIB Germicidal Soap is not the subject of an approved new drug application; therefore, the introduction or delivery for introduction of this product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d), and violates section 505 of the FD&C Act.
More information on both warning letters can be found here.