# FDA WARNING_LETTER - Amcyte Pharma, Inc. - December 20, 2021

Source: https://www.keypedia.com/records/warning_letter/amcyte-pharma-inc/f4fc7a95-71c8-4b50-b2a4-31842614795a

> FDA WARNING_LETTER for Amcyte Pharma, Inc. on December 20, 2021. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Amcyte Pharma, Inc.
- Inspection Date: 2021-12-20
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On January 3, 2022, the FDA issued a Warning Letter to the operator of https://nasitrol.com/ following a December 20, 2021, website review. The FDA found that Nasitrol was offered for sale in the U.S. with claims to mitigate, prevent, treat, diagnose, or cure COVID-19. This renders Nasitrol an unapproved new drug, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and a misbranded drug under section 502 (21 U.S.C. § 352).

The introduction of this product into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act (21 U.S.C. § 331(a) and (d)). The FDA emphasized its urgent measures to protect consumers from unapproved products claiming to address COVID-19, given the public health and national emergencies declared for the pandemic.

The letter demands immediate action to cease the sale of all unapproved and unauthorized COVID-19-related products. The recipient must email COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours, detailing specific corrective steps, including documentation, to prevent recurrence. Failure to comply

## Related Officers

- [Director](https://www.keypedia.com/people/donald-d-ashley/060f0dda-e6e8-4f9c-97e7-f540d523d902)

Company: https://www.keypedia.com/companies/amcyte-pharma-inc/0ec04a6c-3d0a-4aa5-8ef6-b48c02d06149

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