Integrity Partners Group

Warning LetterOpen

Mr. Darren J. Birkelbach Chief Executive Officer Integrity Partners Group 1111 Industry Avenue SE Roanoke , VA 24013 United States dbirkelbach@integritypartnersgrp.comFEI 1000158477Issued Dec 15, 2025Center for Drug Evaluation and Research (CDER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 1000158477.

Violations5

Issue DateDec 15, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Integrity Partners Group
Location: Mr. Darren J. Birkelbach Chief Executive Officer Integrity Partners Group 1111 Industry Avenue SE Roanoke , VA 24013 United States dbirkelbach@integritypartnersgrp.com
FEI Number: 1000158477
Country: United States
Issue Date: December 15, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Integrity Partners Group's manufacturing facility failed to adequately test over-the-counter drug products for active ingredient strength (assay) and microbiological contamination prior to release and distribution, violating Current Good Manufacturing Practice (CGMP) requirements under 21 CFR 211.165(a) and (b). The FDA inspection of the Chemisphere Corporation facility in Saint Louis, Missouri from June 16-24, 2025 determined that these testing deficiencies rendered the finished drug products adulterated. Without appropriate pre-release testing to verify identity, strength, quality, and purity, the company could not ensure its drug products conformed to predetermined quality standards and were safe for their intended use.

Integrity Partners Group FDA Warning Letter, December 15, 2025