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Swiss-American CDMO, LLC — FDA Facility Profile

FEI 3001451826

Swiss-American CDMO, LLC is an FDA-registered facility (FEI 3001451826) located in CARROLLTON, TX, US. Registered operations: MANUFACTURE. RegDataLab tracks 9 FDA inspections at this facility.

Facility Details

Location
CARROLLTON, TX (US)
Registration Expires
December 31, 2026
Operations
MANUFACTURE
Source
both

Recent inspections

  • 1251710 (NAI Mon Dec 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1193281 (VAI Mon Dec 19 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1165937 (VAI Thu Mar 31 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1114623 (NAI Thu Dec 12 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1067042 (NAI Fri Sep 28 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 928487 (NAI Thu Jun 04 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 712969 (NAI Tue Mar 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 667023 (NAI Fri Jun 11 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 599251 (NAI Mon Jul 27 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • 799-6210849-9/1/1B (Tue Aug 23 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • T94-0059995-5/1/1 (Mon Jul 22 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources