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The U.S. Food and Drug Administration (FDA) has issued warning letters to 12 companies for selling illicit skin brighteners. An FDA Warning Letter is typically issued because an issue that was found during an FDA inspection was egregious or because an observation on the FDA Form 483 was never properly addressed. 355h(a)(4), and because it is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. Accordingly, this skin bleaching drug product is an unapproved new drug and its introduction or delivery for introduction into interstate commerce violates section 505(a) of the FD&C Act, 21 U.S.C. Fresno, CA 93727-7408 o Drugs with higher drug potencies Your firm also failed to validate and establish the reliability of your component suppliers test analyses at appropriate intervals (21 CFR 211.84(d)(1) and (2)). 355, and does not comply with the requirements under section 505G of the FD&C Act, 21 U.S.C. Address how your firm will ensure all phases of investigations are appropriately conducted. For more information about handling failing, OOS, out-of-trend, or other unexpected results and documentation of your investigations, see the FDAs guidance document Investigating OOS Test Results for Pharmaceutical Production at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigating-out-specification-test-results-pharmaceutical-production. U.S. Food and Drug Administration DATE: 10/5/2022 Case #: 634233. The warning letters included citations for claims such as: "[A] treatment that helps reduce blood sugar levels, control glucose, improve conditions for diabetic people . Hindi () | Korean () | Simplified Chinese () | Somali (somaliyeed) | Spanish (Espaol) | Tagalog (Tagalog) | Vietnamese (Ting Vit). Specifically, this skin bleaching product falls under section 505G(a)(4) of the FD&C Act, 21 U.S.C. 331(d). YES NO Your chances of being served with an FDA warning letter are markedly reduced. FDA encourages health care professionals and consumers to report adverse reactions or quality problems experienced with the use of these products to the FDAs MedWatch Adverse Event Reporting program by: The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Please identify your response with unique identifier CMS 618333. Dear Mr. Patel: The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Lupin Limited, FEI 3002807512, at T-142, MIDC Tarapur via Boisar, Palghar, from March 22 to April 4, 2022. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. Labeling FDA Approved Products. However, the FDA has still received several dietary supplement claims notifications including NAC as an ingredient tied to a structure/function claim. The .gov means its official.Federal government websites often end in .gov or .mil. It has advised people to not use such products as they may result in conditions such as ochronosis, a bluish-black or grey-blue discoloration of the skin, which could be permanent. Your response is inadequate. 351(a)(2)(B). 352(ee), because these products are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. Hydroquinone impacts this phenomenon (known as melanogenesis) in a couple of ways: So, technically speaking, hydroquinone isn't a bleach. Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)). United States. A mid-sized company received a 10-item FDA 483. Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. However, a meeting with a compliance officer is not necessarily . o Maximum hold times before cleaning Then if you do happen to get an FDA warning letter, you absolutely MUST respond and correct the issues. Examples of the claims observed on your product label and labeling from your website https://www.SKINPRO.com, where the product is available for purchase, that provide evidence of the intended use (as defined in 21 CFR 201.128) of your product include, but may not be limited to, the following: ULTRA BRIGHT LIGHTENING CREAM Maximum Strength Hydroquinone [from SKINPRO ULTRA BRIGHTENER HYDROQUINONE product label], With a maximum strength of Hydroquinone in the highest allowable amount, the Ultra Brightening Skin Lightener from SkinPros Medical Grade Skin Care line of products works fast to eradicate dark spots and prevent future occurrences of hyperpigmentation and uneven skin tone. [from your website https://www.skinpro.com], SKINPRO ULTRA BRIGHTENER HYDROQUINONE is a skin bleaching drug subject to section 505G of the FD&C Act, 21 U.S.C. Therefore, you must present a plan including corrective actions that you will take by writing a response letter or meeting with the assigned Compliance Officer. 2 FDA did not determine that it was in the interest of public health to extend the period during which any drugs subject to section 505G(a)(4) may be marketed without such an approved new drug application. A detailed program for designing, validating, maintaining, controlling, and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Inadequate removal of active ingredients and residues from manufacturing equipment during cleaning can result in cross-contamination of your drug products. WARNING LETTER March 1, 2022 Dear Mrs. Daliva-Banks: The U.S. Food and Drug Administration inspected your drug manufacturing facility, Generitech Corporation, FEI 3002994577, at 4967 E. 352(ee). You failed to demonstrate that your cleaning and disinfection practices are adequate to remove contaminants from the shared equipment used to manufacture both topical OTC The site is secure. You failed to appropriately validate your processes and adequately qualify the equipment used to manufacture your topical OTC drug products. FDA is alerting consumers there are no FDA-approved or otherwise legally marketed OTC skin lightening products. You also stated you will develop a more comprehensive corrective action and preventive action (CAPA) program and train your personnel. Acting Director, Division of Pharmaceutical Quality Operations IV. A summary of your program for qualifying and overseeing contract facilities that test the components for the drug products you manufacture. The most common causes for an FDA warning letters are: 331(d) and (a). Specifically, the company was called out for having no documentation proving that the malfunction would not likely cause or contribute to a death or serious injury. Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company's corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. The agency is notifying companies that have listed these drugs with FDA, but may not actively be distributing them, of the current legal status of these drugs to prevent companies from distributing these illegal products. Since there are no current known treatments or cures for COVID-19, claims that products can provide . Currently, Tri-Luma is the only FDA-approved drug containing hydroquinone. Your response is inadequate because it did not provide sufficient detail or evidence of corrective actions to bring your operations into compliance with CGMP. During our inspection, our investigator observed specific violations including, but not limited to, the following. They were in need of medical device consultants who could provide insight and expertise. These letters: Are published on the FDA's 'warning letter' pages 355h(a)(4), because they are subject to a determination to be not generally recognized as safe and effective (GRASE) in a proposed rule that is the most recently applicable proposal issued under 21 CFR part 330.1 Thus (b)(4) Hydroquinone Cream and (b)(4) are deemed to be new drugs under section 201(p)(1) of the FD&C Act and subject to the requirement to have an approved new drug application under section 505 of the FD&C Act, 21 U.S.C. 1 On August 29, 2006, FDA issued a proposed rule (71 FR 51146) setting forth a determination that OTC skin bleaching drug products, including but not limited to those that contain hydroquinone, are not generally recognized as safe and effective. Typically, FDA Warning Letters are sent to ensure overnight delivery and receipt of delivery (e.g., return receipt requested, FedEx). An official website of the United States government, : 355, beginning on September 23, 2020.2. Specifically, these products are intended for use as skin bleaching drug products. An assessment of each drug product process to ensure that there is a data-driven and scientifically sound program that identifies and controls all sources of variability, such that your production processes, and will consistently meet appropriate specifications and manufacturing standards. 4967 E Lansing Way You failed to appropriately investigate to determine a root cause or assess the impact of your OOS results. Carolyn E. Becker 2 Section 505G(a)(4) of the FD&C Act, 21 U.S.C. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. After you receive this letter, respond to this office in writing within 15 working days. You also failed to implement an appropriate CAPA to mitigate and prevent recurrence. Specifically, your skin bleaching products fall under section 505G(a)(4) of the FD&C Act, 21 U.S.C. Requests to FDA for agency records should be sent to: Food and Drug Administration Division of Freedom of Information (HFI-35), 5630 Fishers Lane, Rockville, MD 20857. We strongly recommend engaging a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(d) and (a) of the FD&C Act, 21 U.S.C. The FDA logo should not be used on a product's labeling whether the product is approved or not.. "/> 901 Pennsylvania Ave, Suite 597 Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, QU oversight, and written procedures. Some manufacturers and distributors have already removed their OTC skin lightening products from the marketplace, and FDA plans to take action against those continuing to market these potentially harmful and illegal OTC products. FDA Warning Letters The U.S. Food and Drug Administration (FDA) has made a number of different non-compliance oversight determinations at institutions over the last several years. Those who fail to comply with the law are subject to FDA action. FDA identifies that similar shortcomings were identified at an inspection conducted in 2017 and, " Repeated failures demonstrate that executive . Instructions for how to submit an FOI request can be found at. o Swabbing locations for areas that are most difficult to clean Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Office of Compliance The CAPA should include, but not be limited to, addressing of the following: Responding to a 483 Warning Letter The first step in addressing Form 483 is to respond verbally to the findings at the end of the inspection. 331(d) and (a). WARNING LETTER. These electronic files were not secured to prevent unauthorized changes, and have no change history.. FDA Warning Letter. FDA is alerting consumers there are no FDA-approved or otherwise legally marketed OTC skin lightening products. Describe improvements to your cleaning and disinfection program, including enhancements to cleaning effectiveness; improved ongoing verification of proper cleaning and disinfection execution for all products and equipment; and all other needed remediations. 355h(a)(4), as added on March 27, 2020 with the enactment of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), because it is subject to a determination to be not generally recognized as safe and effective (GRASE) in a proposed rule that is the most recently applicable proposal issued under 21 CFR part 330.1 Thus, SKINPRO ULTRA BRIGHTENER HYDROQUINONE is deemed to be a new drug under section 201(p)(1) of the FD&C Act and subject to the requirement to have an approved new drug application for marketing under section 505 of the FD&C Act, 21 U.S.C. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure, and injunction. Center for Drug Evaluation and Research You failed to provide adequate details of your validation plan. Hydroquinone USP, 4% Skin Bleaching Cream is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas . The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Consumers should talk to their health care professional about treatment options for certain skin conditions including aged or dark spots. 2. The company responded but subsequently received a Warning Letter. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 3. A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. 331(a). In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. Based upon the nature of the violations we identified at your firm and because you failed to correct repeat violations. These violations are described in more detail below. MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. This is a repeat observation from the previous April 2013, FDA inspection. The .gov means its official.Federal government websites often end in .gov or .mil. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Xeroderma Stinging Rarely ochronosis - ochronosis is a blue-black or gray-blue discoloration; it is rare and more commonly seen in patients that use a high concentration of hydroquinone for a long period on large areas of the body. The U.S. Food and Drug Administration (FDA) said on Tuesday it sent warning letters to twelve companies for selling certain over-the-counter (OTC) skin lightening products which have not. . The assessment should identify any inadequacies of cleaning procedures and practices and encompass each piece of manufacturing equipment used to manufacture more than one product. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. You also stated you will train a technician on how to handle raw material components. Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. As a result of CARES Act, effective September 23, 2020, manufacturers and distributors of OTC skin lightening products that do not have FDA approval must remove the products from the marketplace. Step #2: Conduct an. 355, is in effect for (b)(4) Hydroquinone Cream or (b)(4). Acino Products LLC (Hamilton, NJ) received a warning letter on February 10, 2020, based on the outcome of an inspection ending June 12, 2019. Specifically, you have not completed the appropriate process performance qualification (PPQ) studies for multiple topical OTC drug products, and you do not have a rigorous ongoing program to monitor process control to ensure stable manufacturing operations and consistent drug quality. Requests to FDA for agency records should be sent to: Food and Drug Administration Division of Freedom of Information (HFI-35), 5630 Fishers Lane, Rockville, MD 20857. Eighteen of 21 FDA warning letters issued to cosmetics companies from July 2015 through August 2016 have cited skin-care claims on companies' websites that exceed the cosmetic definition enshrined in the Federal Food, Drug and Cosmetic Act (FDCA). Your firms executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance. According to the FDA, the following companies have received warning letters for continuing to illegally sell these OTC skin lightening products containing hydroquinone: Dr. Thomas. Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. FDA Issues Warning Letters for OTC Skin Lightening Products June 13, 2022 On April 19, 2022, the U.S. Food and Drug Administration (FDA) issued warning letters to 12 firms regarding the presence of the active drug ingredient hydroquinone in over-the-counter (OTC) skin lightening products. We may re-inspect to verify that you have completed corrective actions to address any violations. Consumers should talk to their health care professional about treatment options for certain skin conditions including aged or dark spots. Office of Unapproved Drugs and Labeling Compliance Unapproved New Drug and Misbranding Violations. These products are found to be non-compliant with the existing standards and may cause potential harm to the consuming public. Manufacturers of drugs and devices that do require FDA approval may include the phrase "FDA Approved" on the product's labeling, as long as the manufacturer has received a letter from FDA confirming its approval. 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