The Anthos Group, Inc. – FDA Warning Letter, Nov 8, 2022

This Warning Letter, 320-23-03, dated November 3, 2022, was issued to Mr. Umer, a registered manufacturer of OTC drug products, specifically VERTRA Hand Sanitizer. The FDA initiated an electronic request for records and information on December 4, 2020, under section 704(a)(4) of the FD&C Act. After a second electronic request, the firm responded, stating the request was forwarded to the manufacturer. A follow-up written request sent via certified mail on August 12, 2021, was returned undeliverable, and a phone call went unanswered.

The firm's failure to respond to these communications and provide requested records constitutes a prohibited act under section 301(e) of the FD&C Act (21 U.S.C. 331(e)). Given the history of quality issues with hand sanitizers during the COVID-19 public health emergency, the FDA has no indication of the quality assurance for drugs manufactured at this facility due to the lack of response.

The FDA requires a response within 48 hours to confirm or update registration/drug listing status and indicate whether the firm will respond to the records request. If drug manufacturing has ceased, the firm must delist all drugs and deregister the facility. Non-response may lead to inclusion on the FDA's list of