RegWardenFDA facility compliance records
Facility

ASP Global, LLC

2 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2025: 2 recalls, 1 inspections, 1 warning letters20172018201920202021202220232024420252026
  • Recalls (2)
  • Inspections (1)
  • Warning letters (1)

Devices registered here (1)

Recalls & enforcement

  • Class IIOngoing2025-09-26
    Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
  • Class IIOngoing2025-05-05
    All RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured between July 31, 2023 to February 28, 2025 cause false positive results when used with Magellan Diagnostics LeadCare Testing Systems. False positive lead results may cause delayed results and additional unne…

FDA inspections (1)

  • OAI2025-08-01
    Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ASP Global, LLC (FEI 3004824601) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004824601-asp-global-llc/

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