- Delivery Method:
- VIA UPS
Recipient NameMr. Daniel Chamlati
Recipient TitleChief Executive Officer
- Absara Cosmetics S.A.P.I DE C.V.
Autopista Mexico – Toluca Km. 53.5 Av. Ind. Farmac. Accesso
Parque Industrial Dona Rosa Planta II
52004 Emiliano Zapata,
- Issuing Office:
- Center for Drug Evaluation and Research | CDER
Warning Letter 320-21-26
February 18, 2021
Dear Mr. Chamlati:
Your firm is registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic rub drug product (also referred to as a consumer hand sanitizer), labeled as FRAGRANCE FREE VLANC + PLUR HAND SANITIZER RINSE FREE FORMULATED WITH 70% OF ALCOHOL WITH ALOE VERA & GLYCERIN. This drug product was labeled as manufactured at your facility, Absara Cosmetics S.A.P.I. De C.V., FEI 3012333567, at Autopista Mexico – Toluca Km. 53.5 Av. Ind. Farmac. Accesso, Parque Industrial Dona Rosa Planta II, Emiliano Zapata 52004 Mexico. Following an attempt to import FRAGRANCE FREE VLANC + PLUR HAND SANITIZER RINSE FREE FORMULATED WITH 70% OF ALCOHOL WITH ALOE VERA & GLYCERIN into the United States, it was detained and refused admission at the border.
The results of the FDA laboratory testing of a batch of this product detained at the border demonstrate that this drug product labeled as manufactured at your facility is adulterated within the meaning of section 501(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act or Act), 21 U.S.C. 351(c), in that its strength, purity, or quality falls below that which it purports or is represented to possess. In addition, this product is adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)), in that the subpotency demonstrates that the quality assurance within your facility is not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements.
FRAGRANCE FREE VLANC + PLUR HAND SANITIZER RINSE FREE FORMULATED WITH 70% OF ALCOHOL WITH ALOE VERA & GLYCERIN, labeled as manufactured at your facility, is labeled to contain 70% volume/volume (v/v) of the active ingredient alcohol (ethanol). However, FDA laboratory testing of a batch of this product detained at the border found that the drug product contained only 58% v/v ethanol. This hand sanitizer drug product is adulterated under section 501(c) of the FD&C Act in that the active ingredient of ethanol is present at levels in the products lower than that which is declared on its labeling.
CDC recommends1 that, if soap and water are not readily available, consumers use an alcohol-based hand sanitizer that contains not less than 60% alcohol (ethanol). This is the minimum active ingredient concentration of ethanol specified in the 1994 Tentative Final Monograph for Health-Care Antiseptic Drug Products (59 FR 31402), as further amended by “Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record,” Proposed Rule, 81 FR 42912 (June 30, 2016).
On October 16, 2020, FDA held a teleconference with you. While the subpotent drug product detailed above was shipped to the United States, information available to FDA demonstrated that all of your hand sanitizers were detained and refused admission at the border and did not enter the United States. We requested additional information concerning your CGMP operations, including test methods for your finished drug product, documentation showing equivalence with USP test methods, and your investigation into the subpotent lot tested by FDA. In your responses, you provided details on the in-house testing that you are using to test your drug products, but did not provide any documentation for method validation or describing equivalence to relevant USP test methods. The methods provided showed differences from USP methods without justification and did not describe an internal standard, system suitability, and contained calculation errors. Failure to have adequate test methods is a violation of CGMP requirements (see 21 CFR 211.160).
In addition to your test methods, you submitted the results of your investigation into the subpotent batch the FDA tested. Your investigation concluded that the subpotency issue is limited to only the FDA-tested batch. However, you did not provide adequate scientific justification to support that conclusion. Therefore, it is unclear whether you correctly identified the root cause and adequately expanded the investigation to include all impacted products and batches. In addition, your investigation did not include a review of your test methods, laboratory operations, and analytical results. Failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed, is a violation of CGMP requirements (see 21 CFR 211.192).
In response to this letter provide the following:
• A detailed follow-up investigation into how the hand sanitizer drug products described above, which were labeled as containing 70% ethanol, in fact contained an average of 58% ethanol, respectively. This follow-up investigation should identify the specific batches in each identified import entry that may have been impacted, and include a thorough review of laboratory methods and procedures used to analyze the impacted batches.
• A list of all raw materials used to manufacture your hand sanitizer drug products, including the suppliers’ names, addresses, and contact information.
• A list of all batches of any hand sanitizer drug products shipped to the United States by your firm, and a full reconciliation of all material you distributed.
• Copies of the complete batch records for all batches distributed to the United States.
• A list of appropriate chemical and microbial test methods and specifications used to analyze each lot of your components and drug product before making a lot disposition decision, and the associated written procedures.
The subpotency of hand sanitizer drug products declared or labeled as manufactured in your facility demonstrates that the quality assurance within your facility is not functioning in accordance with CGMP requirements under section 501(a)(2)(B) of the FD&C Act.2
CGMP Consultant Recommended
Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements if your firm intends to resume manufacturing drugs for the U.S. market. We also recommend that the qualified consultant perform a comprehensive audit of your entire operation for CGMP compliance and that the consultant evaluates the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.
The violations cited in this letter are not intended to be an all-inclusive list of violations associated with your drug products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.
Note that FDA placed all drugs and drug products manufactured by your firm on Import Alert 66-78 on February 4, 2021, as the methods used in and controls used for the manufacture, processing, packing, or holding of these products do not appear to conform to current good manufacturing practices within the meaning of section 501(a)(2)(B) of the FD&C Act. Drugs and drug products that appear to be adulterated or misbranded may be detained or refused admission without physical examination.
All drugs and drug products manufactured by your firm may remain listed on this import alert until there is evidence establishing that the conditions that gave rise to the appearance of a violation have been resolved, and the Agency has confidence that future entries will be in compliance with the Act. This may include an inspection prior to the Agency considering the appearance of adulteration to be addressed.
If you decide you want to manufacture drugs for the United States in the future, request a Regulatory Meeting to discuss corrective actions.
This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot do so within 15 working days, state your reasons for delay and your schedule for completion.
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov.
Please identify your response with FEI 3012333567 and ATTN: Marisa Heayn.
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
David Lennarz, U.S. Agent
144 Research Drive
Hampton, VA 23666 USA
2 Due to an increased demand for alcohol-based hand sanitizers during the COVID-19 pandemic, FDA published the Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) on March 19, 2020, and subsequently updated the guidance several times, most recently on February 10, 2021. This guidance communicates the Agency’s temporary policy that we do not intend to take action against firms for CGMP violations under section 501(a)(2)(B) of the FD&C Act if such firms prepare alcohol-based hand sanitizers for consumer use (or for use as a health care personnel hand rub) during the public health emergency, provided certain circumstances described in the guidance are present. These circumstances include preparation of hand sanitizer products using only the ingredients and formulas set forth in the guidance. In addition to the violative testing results detailed above that demonstrate the subpotency of hand sanitizer products labeled as manufactured at your facility, a review of the purported formulations on the drug products’ labeling further indicates that this product is not prepared consistent with FDA’s temporary policy set forth in the guidance. Therefore, this product does not fall within the Agency’s temporary policy not to take action against firms manufacturing hand sanitizer products for violations of section 501(a)(2)(B) of the FD&C Act.