# FDA WARNING_LETTER - The Anthos Group, Inc. - November 08, 2022

Source: https://www.keypedia.com/records/warning_letter/the-anthos-group-inc/e167b79a-4b8f-4809-bd43-92f62a2eb970

> FDA WARNING_LETTER for The Anthos Group, Inc. on November 08, 2022. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: The Anthos Group, Inc.
- Inspection Date: 2022-11-08
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Officers

- [Director](https://www.keypedia.com/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)

Company: https://www.keypedia.com/companies/the-anthos-group-inc/64c9d5cc-153c-4c58-a885-47b856d99da5

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c