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1251710

Swiss American CDMO, LLC — FEI 3001451826

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
December 16, 2024
Fiscal Year
2025
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Carrollton, TX (United States)

Facility

Other inspections at this facility

  • 1193281 (NAI 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))

Citations

IDCFRDescription
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
54621 CFR 820.75(a)Lack of or inadequate process validation