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Warning Letter 320-23-33

August 7, 2023

Dear Mr. Velázquez:

Your firm is registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic hand rub drug product (also referred to as a consumer hand sanitizer), labeled as Instant Hand Sanitizer LaavoClean without Alcohol and Instant Hand Sanitizer LaavoClean KIDS without Alcohol. These drug products were labeled as being manufactured at your facility, Laavo Clean, S.A. de C.V., FEI 3017301021, at Elias Flores Sur. No. 300, Apodaca Centro, Ciudad Apodaca, Nuevo Leon 66600, Mexico. Following an attempt to import Instant Hand Santizer LaavoClean without Alcohol and Instant Hand Sanitizer LaavoClean KIDS without Alcohol into the United States, they were detained and refused admission at the border.

The results of the FDA laboratory testing of batches of these products detained at the border demonstrate that these drug products, labeled as being manufactured at your facility, are 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 their strength differs from, or their purity or quality falls below, that which they purport or are represented to possess.

Adulteration Violations

Instant Hand Sanitizer LaavoClean KIDS without Alcohol, labeled as being manufactured at your facility, is labeled to contain 0.13% of the active ingredient benzalkonium chloride (BZK). However, FDA laboratory testing of a batch of this product detained at the border found that the drug product contained an average of 0.15% w/v BZK, or 115% of the label claim (United States Pharmacopeia (USP) Limits: NLT 93.0% and NMT 107.0%). Additionally, Instant Hand Sanitizer LaavoClean without Alcohol, labeled as being manufactured at your facility, is labeled to contain 0.13% of the active ingredient BZK. However, FDA laboratory testing of two batches of this product detained at the border found that the drug products contained an average of 0.15% and 0.12% w/v BZK, or 92.7% of the label claim, respectively (USP Limits: NLT 93.0% and NMT 107.0%).

These hand sanitizer drug products are adulterated under section 501(c) of the FD&C Act in that the active ingredient of BZK is present at levels that differ than that which is declared on their labeling.

While the drug products detailed above were 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. Therefore, FDA did not recommend that you remove these products from the market.

On May 17, 2023, FDA notified the public of the subpotency and superpotency of your hand sanitizer drug products at the following webpage: 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 detailed investigation into how the hand sanitizer drug products described above, labeled as containing 0.13% BZK, in fact contained an average of 0.15% BZK and 0.12% BZK, respectively.
• 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 any 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 any batches distributed to the United States.

Conclusion

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 May 9, 2023, and accordingly drugs and drug products that appear to be adulterated 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 FD&C 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 3017301021 and ATTN: Philip Kreiter.

Sincerely,
/S/
Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research