ASP Global, LLC. dba Anatomy Supply Partners, LLC.

Warning LetterOpen

Doug Shaver Chief Executive Officer ASP Global, LLC. dba Anatomy Supply Partners, LLC. 7800 Third Flag Pkwy Austell , GA 30168-7657 United States doug.shaver@aspglobal.comFEI 3004824601Issued Dec 9, 2025Center for Devices and Radiological Health

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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 3004824601.

Violations11

Issue DateDec 9, 2025

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Location: Doug Shaver Chief Executive Officer ASP Global, LLC. dba Anatomy Supply Partners, LLC. 7800 Third Flag Pkwy Austell , GA 30168-7657 United States doug.shaver@aspglobal.com
FEI Number: 3004824601
Country: United States
Issue Date: December 09, 2025
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

ASP Global, LLC. dba Anatomy Supply Partners, LLC. manufactured the Safe-T-Fill Micro Capillary Collection System, a medical device intended for disease diagnosis and monitoring, which was found to be adulterated due to failures to comply with Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Part 820. During an inspection conducted July 28–August 1, 2025, the FDA identified multiple Quality System Regulation violations, including failure to establish adequate supplier management procedures to ensure that critical products purchased from the manufacturer of the Safe-T-Fill Capillary Collection Tubes conformed to specified requirements under 21 CFR 820.50. The company submitted a response to the FDA's Form 483 observations on August 22, 2025, but the violations remained unresolved.

ASP Global, LLC. dba Anatomy Supply Partners, LLC. FDA Warning Letter, December 9, 2025