"Daniel C. Tarquinio, D.O./Center for Rare Neurological Diseases

Warning LetterOpen

"Daniel C. Tarquinio, D.O./Center for Rare Neurological Diseases 5600 Oakbrook Parkway, Building 100, Suite 120 Norcross , GA 30093-1843 United States (b)(6) (b)(6)Issued Apr 5, 2022Center for Drug Evaluation and Research | CDER

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateApr 5, 2022

Product TypeOther

StatusOpen

Letter Details

Firm: "Daniel C. Tarquinio, D.O./Center for Rare Neurological Diseases
Location: "Daniel C. Tarquinio, D.O./Center for Rare Neurological Diseases 5600 Oakbrook Parkway, Building 100, Suite 120 Norcross , GA 30093-1843 United States (b)(6) (b)(6)
FEI Number: N/A
Country: United States
Issue Date: April 05, 2022
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Other
Status: Open

Summary

Daniel C. Tarquinio, D.O./Center for Rare Neurological Diseases received a warning for violations in the conduct of clinical drug investigations identified during an FDA Bioresearch Monitoring inspection conducted from October 18 to November 5, 2021. The primary violation cited was failure to ensure that clinical investigations were conducted according to the investigational plan, as required under 21 CFR 312.60, specifically regarding subject enrollment procedures in Protocol transition studies. The inspection found that the investigator did not adhere to applicable statutory requirements under the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 312 governing clinical investigations and human subject protection.

"Daniel C. Tarquinio, D.O./Center for Rare Neurological Diseases FDA Warning Letter, April 5, 2022