FDA inspection

Sea-Long Medical Systems, LLC: FDA inspection ending Nov 5, 2024

FDA inspection 1254427 · Official Action Indicated (OAI) · Waxahachie, TX

Key facts

Inspection ID 1254427
Firm Sea-Long Medical Systems, LLC
FEI number 1037230
Address 2498 Fm 66 Building 1021
City Waxahachie
State TX
ZIP 75167
Country United States
Fiscal year 2025
Inspection end date Nov 5, 2024
Classification Official Action Indicated (OAI)
Project area Compliance: Devices
Product type Devices

At a glance

  • 10–99 Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 1–9 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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