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# Multiple Violations Seen in ASP Global Inspection
- URL: https://www.fdaweb.com/multiple-violations-seen-in-asp-global-inspection/
- Published: 2026-01-14T12:00:00.000Z
- Updated: 2026-09-14T15:30:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160489

A 7/18-8/1/2025 FDA inspection at ASP Global, doing business as Anatomy Supply Partners in Austell, GA, found multiple violations in the firm’s manufacturing of the Safe-T-Fill Micro Capillary Collection System. A just-released 12/9/2025 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/asp-global-llc-dba-anatomy-supply-partners-llc-718444-12092025?ref=fdaweb.com) cited these specific Quality System Regulation, Medical Device Reporting, Corrections and Removal, Unapproved Device, and Labeling violations:

- failure to adequately establish procedures to ensure that all purchased or otherwise received products and services conform to specified requirements;
- failure to adequately develop, maintain, and implement written Medical Device Reporting procedures;
- failure to submit a written report to FDA of any correction or removal of a device initiated to remedy a violation of the Federal Food, Drug, and Cosmetic Act caused by the device, which may present a risk to health;
- making significant changes or modifications to an original device that was cleared by FDA and for which the company lacks clearance or approval; and
- failure of the labeling to contain adequate directions for use.

ASP was told to correct the violations promptly and to respond with a list of specific actions it has taken to correct the violations and prevent their recurrence, with documentation for each action and a schedule for completing the corrections.