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Warning Letter 320-22-14

May 2, 2022

Dear Mr. Lee:

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 CALA Advanced Hand Sanitizer Moisturizing with Aloe Vera Extract. This drug product was manufactured at your facility, David Cosmetic Co., Ltd. at 14 Dodam 8-ro, Seo-gu, Incheon, Republic of Korea, and distributed in the U.S.

The results of the FDA laboratory testing of a batch of this product in U.S. distribution demonstrate that this drug product manufactured at your facility is adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B))¹, in that contamination with the impurity benzene at unacceptable levels demonstrates that the quality assurance within your facility is not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements.

Adulteration Violations

CALA Advanced Hand Sanitizer Moisturizing with Aloe Vera Extract was manufactured at your facility. FDA laboratory testing of a batch of this product in U.S. distribution found that the drug product contained impurities at unacceptable levels. Benzene impurity levels were found to be approximately 6 parts per million (ppm).

Manufacturers should not use benzene in the manufacture of drugs because it is a known human carcinogen that causes leukemia and other blood disorders. FDA has alerted all drug manufacturers to the known risk factors for contamination with benzene. For more information https://www.fda.gov/drugs/pharmaceutical-quality-resources/fda-alerts-drug-manufacturers-risk-benzene-contamination-certain-drugs.

On December 27, 2021, FDA held a teleconference with you. We recommended you consider removing the adulterated batch of CALA Advanced Hand Sanitizer Moisturizing with Aloe Vera Extract currently in distribution from the U.S. market. You committed to recalling the adulterated batch in a December 28, 2021 communication to FDA. In response to FDA’s request during the teleconference for impurity testing results, you responded in a December 29, 2021 communication, stating that you do not conduct impurity testing, including for benzene, of active pharmaceutical ingredients or for your finished hand sanitizer drug products. Because benzene contamination is a known risk of the manufacturing process, a finished product specification for benzene in hand sanitizers is appropriate under 21 CFR 211.160(b). Further, finished product testing of each batch of drug product is required under 21 CFR 211.165. As of the date of this letter, you have yet to initiate a recall.

On January 12, 2022, FDA notified the public of the unacceptable benzene results in your hand sanitizer drugs products 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:

• A detailed investigation into how the hand sanitizer drug product described above, which was manufactured at your facility contained unacceptable levels of benzene contamination.
• 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 U.S. by your firm, and a full reconciliation of all material you distributed.
• Copies of the complete batch records for all batches distributed to the U.S.
• Methanol, benzene, acetal, acetaldehyde and test results for all hand sanitizer batches released and distributed.

The contamination with benzene in a drug product manufactured in your facility, in addition to the deficiencies in your response to the information we requested during the December 27, 2021 teleconference, demonstrate 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.

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.

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 March 10, 2022, 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 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 [email protected]. Identify your response with FEI 3015781135 and ATTN: Rory Geyer.

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

CC:
Registered U.S. Agent
Yang Ho Dong
Onbix Corporation
102 North G. Street, Unit 105
Tacoma, WA 98403-2259
[email protected]

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1 We note that your drug product also does not conform to any temporary policy FDA has implemented during the public health emergency. In March 2020, the Agency published three guidance documents to provide regulatory flexibility to certain firms to help meet the demand for alcohol-based hand sanitizer during the COVID-19 public health emergency (PHE). Additionally, on December 31, 2021 these guidances were withdrawn, and firms were required to cease distribution, by March 31, 2022, of any remaining hand sanitizer products that were prepared under the temporary policies before or on December 31, 2021. See, 86 FR 56960, October 13, 2021.