FDA inspection

Swiss American CDMO, LLC: FDA inspection ending Dec 19, 2022

FDA inspection 1193281 · Voluntary Action Indicated (VAI) · Carrollton, TX

Key facts

Inspection ID 1193281
Firm Swiss American CDMO, LLC
FEI number 3001451826
Address 2055 Luna Rd Ste 126
City Carrollton
State TX
ZIP 75006
Country United States
Fiscal year 2023
Inspection end date Dec 19, 2022
Classification Voluntary Action Indicated (VAI)
Project area Postmarket Assurance: Devices
Product type Devices

At a glance

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