RAAS Nutritionals, LLC/Rare Antibody Antigen Supply, Inc.

Warning LetterOpen

Kieu Hoang Chief Executive Officer RAAS Nutritionals, LLC/Rare Antibody Antigen Supply, Inc. 3615 Old Conejo Road Thousand Oaks , CA 91320-2123 United States (b)(6)Issued Sep 30, 2021Center for Drug Evaluation and Research | CDER

View Letter

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

Violations3

Issue DateSep 30, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: RAAS Nutritionals, LLC/Rare Antibody Antigen Supply, Inc.
Location: Kieu Hoang Chief Executive Officer RAAS Nutritionals, LLC/Rare Antibody Antigen Supply, Inc. 3615 Old Conejo Road Thousand Oaks , CA 91320-2123 United States (b)(6)
FEI Number: N/A
Country: United States
Issue Date: September 30, 2021
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

RAAS Nutritionals, LLC/Rare Antibody Antigen Supply, Inc. was cited for failing to submit required Investigational New Drug (IND) applications before conducting clinical investigations with investigational drugs, violating 21 CFR 312.20 and 312.40. During a March 2021 FDA Bioresearch Monitoring Program inspection, investigators found that the company, acting as a sponsor of multiple clinical studies, did not adhere to statutory requirements under the Federal Food, Drug, and Cosmetic Act and applicable regulations governing the conduct of clinical investigations and protection of human subjects. The company's April 2021 response to the initial inspectional observations did not adequately address these serious compliance failures related to IND submission requirements.

RAAS Nutritionals, LLC/Rare Antibody Antigen Supply, Inc. FDA Warning Letter, September 30, 2021