> ## 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-18/
- Published: 2020-04-07T12:00:00.000Z
- Updated: 2026-09-14T16:10:15.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5146515

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

**Global Treat Srl**, Galati, Romania (3/31): FDA inspected the firm 9/2019 and cited significant GMPs for finished pharmaceuticals. For example, Global Treat failed to perform, for each batch of drug product, appropriate laboratory determinations of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient. Additionally, it failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. And it failed to validate and establish the reliability of its component supplier’s test analyses at appropriate intervals. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/global-treat-srl-596638-03312020?ref=fdaweb.com).  

**Mandelay Kft**, Pest, Hungary (2/3): FDA inspected the firm 10/2019 and cited GMP deficiencies related to its Scientific Consciousness Interface Operation System and the Quantum University Energetic System Technology devices. For example, the company failed to establish and maintain adequate procedures to control the design of its devices in order to ensure that specified design requirements are met. Mandelay also failed to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mandelay-kft-603799-02032020?ref=fdaweb.com).  

**Philip Kennedy**, Duluth, GA (2/27): FDA inspected the clinical investigator’s site 10/2019 and cited several human subject protection violations related to a undisclosed medical device study. For example, Kennedy failed to ensure proper monitoring and Institutional Review Board review and approval. He also failed to submit complete and accurate progress reports to the IRB. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kennedy-philip-r-597587-02272020?ref=fdaweb.com).