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1110847

McGuff Pharmaceuticals, Inc. — FEI 2022073

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 22, 2019
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Santa Ana, CA (United States)

Facility

Other inspections at this facility

  • 1268175 (OAI Mon Apr 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1229677 (NAI Tue Aug 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1083919 (VAI Tue Mar 26 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1013240 (NAI Fri Jun 02 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 908368 (OAI Wed Dec 31 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
18938FDCA 501(a)(2)(A)Hazardous drugs, prevention of cross-contamination
18949FDCA 501(a)(2)(A)First pass air blockage, open unit with sterile product
18960FDCA 501(a)(2)(A)Flow of personnel and materials, facility
18964FDCA 501(a)(2)(A)Unsealed HEPA filter, perimeter
18972FDCA 501(a)(2)(A)Inadequate sporicidal agents, cleanroom and ISO 5 area
18973FDCA 501(a)(2)(A)Disinfecting materials, aseptic processing area
21377FDCA 501(a)(2)(A)Use of non-pharmaceutical grade components