Frozen Wheels, LLC

WARNING LETTER Frozen Wheels, LLC MARCS-CMS 619443 — December 20, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Isaac Halwani Recipient Title Owner Frozen Wheels, LLC 16565 NW 15th Ave Miami , FL 33169 United States isaac@frozenwheels.com Issuing Office: Division of Pharmaceutical Quality Operations II United States December 20, 2021 Case #: 619443 WARNING LETTER Mr. Halwani: Your firm was registered as a drug repacker. The U.S. Food and Drug Administration (FDA) conducted testing of consumer antiseptic hand rubs (also referred to as a consumer hand sanitizers) labeled as “Greenfrog HAND SANITIZER,” “Cleansepure,” and “Antibacterial Gel, 70% Ethanol Concentration.” Following an attempted import into the United States, “Greenfrog HAND SANITIZER,” “Cleansepure,” and “Antibacterial Gel, 70% Ethanol Concentration” were detained and refused admission at the border. The three drug products listed above were among the many shipments of consumer antiseptic hand sanitizers you attempted to import into the United States for interstate commerce between April 2020 to June 2020. The results of FDA laboratory testing of batches of “Greenfrog HAND SANITIZER,” “Cleansepure,” and “Antibacterial Gel, 70% Ethanol Concentration” drug products detained at the border demonstrate that these drug products are adulterated within the meaning of section 501(d)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act), 21 U.S.C. 351(d)(2), in that a substance was substituted wholly or in part therefor. 1 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. 331(a). These violations are described in more detail below. Introduction or Delivery for Introduction of Adulterated Drugs 1. Greenfrog HAND SANITIZER Import and invoice records reviewed indicated that you attempted to import Greenfrog HAND SANITIZER, a drug product. Greenfrog HAND SANITIZER is labeled to contain 70% volume/volume (v/v) of the active ingredient alcohol (ethyl alcohol). However, FDA laboratory testing of a batch of this product detained at the border found that the drug you attempted to import contained an average of 0% ethyl alcohol and 54% of methanol v/v. The Greenfrog HAND SANITIZER drug product you attempted to introduce into interstate commerce is adulterated under section 501(d)(2) of the FD&C Act in that the active ingredient of ethyl alcohol was substituted wholly or in part with methanol, a dangerous chemical when in contact with human skin or ingested. 2. Cleansepure Import and invoice records reviewed indicated that you also attempted to import Cleansepure, another drug product. Cleansepure is also 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 you attempted to import contained an average of 9.6% ethyl alcohol and an average of 58% of methanol v/v. Therefore, the Cleansepure hand sanitizer drug product you attempted to introduced into interstate commerce is also adulterated under section 501(d)(2) of the FD&C Act in that the active ingredient of ethyl alcohol was substituted wholly or in part with methanol, a dangerous chemical when in contact with human skin or ingested. 3. Antibacterial Gel, 70% Ethanol Concentration Import and invoice records reviewed indicated that you attempted to import Antibacterial Gel, 70% Ethanol Concentration, a drug product. Antibacterial Gel, 70% Ethanol Concentration is labeled to contain 70% volume/volume (v/v) of the active ingredient alcohol (ethyl alcohol). However, FDA laboratory testing of this product detained at the border found that the drug you attempted to import contained < 0.25% of ethyl alcohol and instead was comprised of 63% isopropanol. Therefore, the Antibacterial Gel, 70% Ethanol Concentration hand sanitizer drug product you attempted to introduce into interstate commerce is adulterated under section 501(d)(2) of the FD&C Act in that the active ingredient of ethyl alcohol was substituted wholly or in part with (b)(4) , an undeclared active ingredient. On August 3, 2020 and September 11, 2020, FDA notified the public of the methanol contamination in Greenfrog HAND SANITIZER and Cleansepure at the following website: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use In response to this letter provide the following: A list of all suppliers for your hand sanitizer drug products, including the suppliers’ names, addresses, and contact information. A list of all batches of any hand sanitizer drug products imported into the United States by your firm, and a full reconciliation of all material you distributed. Copies of the drug supply chain custody information for all drug product batches distributed to the U.S. Conclusion Violations in this letter are not intended as an all-inclusive list of violations. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. 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. Your written notification should refer to case # 619443 . Please electronically submit your reply, on company letterhead, to Mark W. Rivero, Compliance Officer, at ORAPHARM2_RESPONSES@fda.hhs.gov. In addition, please submit a signed copy of your response to mark.rivero@fda.hhs.gov. If you have questions regarding the contents of this letter, you may contact NAME via phone at (504) 846-6103 or email at mark.rivero@fda.hhs.gov. Sincerely, /S/ Monica R. Maxwell Program Division Director Office of Pharmaceutical Quality Operations, Division II _________________________________ 1 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. As detailed below, a review of the hand sanitizer products you attempted to import into the United States indicate that these products are not prepared consistent with FDA’s temporary policy set forth in the guidance. Content current as of: 02/01/2022 Regulated Product(s) Drugs