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1165937

Swiss American CDMO, LLC — FEI 3001451826

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 31, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Carrollton, TX (United States)

Facility

Other inspections at this facility

  • 1251710 (NAI Mon Dec 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1193281 (NAI Mon Dec 19 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
113321 CFR 211.25(a)GMP Training Frequency
139621 CFR 211.42(c)(2)Rejected Material Area
202721 CFR 211.192Investigations of discrepancies, failures
241921 CFR 211.198(a)Complaint Handling Procedure
357421 CFR 211.101(b)(1)Subdivided component container identification
430321 CFR 211.67(b)Written procedures fail to include
434221 CFR 211.142(b)Storage under appropriate conditions