Home / Inspections / 1228221

1228221

Allermed Laboratories, Inc. — FEI 1000098920

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 31, 2024
Fiscal Year
2024
Product Type
Biologics
Project Area
Vaccines and Allergenic Products
Location
San Diego, CA (United States)

Facility

Other inspections at this facility

  • 1071500 (VAI Mon Nov 12 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1022877 (VAI Wed Jun 14 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 933388 (VAI Mon Jul 13 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 843070 (VAI Mon Aug 12 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 749646 (VAI Tue Sep 27 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
115921 CFR 211.28(a)Clothing appropriate for duties performed
116921 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
117721 CFR 211.63Equipment Design, Size and Location
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145121 CFR 211.113(b)Procedures for sterile drug products
194221 CFR 211.180(e)Records reviewed annually
356521 CFR 211.58Buildings not maintained in good state of repair
900121 CFR 211.22(a)Lack of quality control unit
908921 CFR 600.14(c)When to report
909521 CFR 600.80(c)(1)(i)Reporting Requirements - 15-day alert