- Delivery Method:
- VIA UPS
Recipient NameMr. Shan Umer
- The Anthos Group, Inc.
705 N Douglas Street
El Segundo, CA 90245
- Issuing Office:
- Center for Drug Evaluation and Research | CDER
Warning Letter 320-23-03
November 3, 2022
Dear Mr. Umer:
Your firm is registered with the United States Food and Drug Administration (FDA or Agency) as a manufacturer of over-the-counter (OTC) drug products; specifically, products including VERTRA Hand Sanitizer. On December 4, 2020, the FDA sent an electronic request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 374(a)(4), to the contact e-mail address provided in your registration file. After a second request was sent to your contact e-mail address, your firm responded stating that you had forwarded FDA’s request to the appropriate manufacturer. The Agency sent a follow-up written request for such records and other information by certified return-receipt mail on August 12, 2021 to the physical address provided in your registration file. The written request was returned after multiple delivery attempts. FDA attempted to contact you at the telephone number provided in your registration file regarding this matter which went unanswered. You failed to respond to these attempted communications or otherwise provide the requested records or other information. Pursuant to section 704(a)(4), FDA’s request and follow-up communication included a sufficient and clear description of the records sought.
It is a prohibited act under section 301(e) of the FD&C Act (21 U.S.C. 331(e)) to refuse to permit access to or copying of any record as required by section 704(a).
Since declaration of the COVID-19 public health emergency,1 a number of hand sanitizer products have been recalled due to quality issues including substitution with other drug substances, impurities at unacceptable levels, and subpotency.2 The Agency has reached out to registered OTC drug firms with hand sanitizers included in their product listing to assess the overall quality of the drugs registered as manufactured by these firms. Because your OTC drug firm failed to respond to the section 704(a)(4) records requests and associated communication attempts, we have no indication of the level of quality assurance for drugs registered as manufactured at your facility.
Respond to this letter within 48 hours to confirm or update your registration and/or drug listing status and indicate whether you will respond to the request for records and other information. If you are no longer manufacturing drugs, delist all the drugs previously listed with FDA, using the last lot expiration date as the marketing end date of the product, and deregister your facility accordingly.
The Agency may conduct an inspection to verify information provided and/or to evaluate the compliance of your manufacturing operations.
Continued non-response regarding questions of the quality assurance of the drugs manufactured at your facility may lead to inclusion on the Agency’s list of hand sanitizers consumers should not use, at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use.
You may provide additional information for our consideration as we continue to assess your activities and practices.
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov.
Identify your response with FEI 3016861323 and ATTN: Rory Geyer.
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research, FDA
1 The HHS Declaration of a Public Health Emergency is available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx.
2 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 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.