> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-44/
- Published: 2020-11-03T12:00:00.000Z
- Updated: 2026-09-14T16:34:56.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5148045

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

**Cosmax USA**, Ridgefield Park, NJ (10/15): FDA inspected the firm in February and found significant GMP violations for finished pharmaceuticals. For example, Cosmax failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. It also failed to establish and follow adequate written procedures for cleaning and maintaining equipment. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cosmax-usa-inc-606909-10152020?ref=fdaweb.com).  

**Immusist LLC**, Gig Harbor, WA (10/16): FDA says its review of a Web site maintained by the company determined that it is selling two unapproved new drugs — Immusist Original and Immusist Natural — intended for use in the cure, mitigation, treatment, or prevention of disease. The agency cited Web site claims and testimonials for the drugs under several disease headings. The letter says the products are not generally recognized as safe and effective for the uses promoted, and they are misbranded. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/immusist-llc-610053-10162020?ref=fdaweb.com).