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696481

Melaleuca Inc — FEI 3021937

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 3, 2010
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Idaho Falls, ID (United States)

Facility

Other inspections at this facility

  • 1278564 (VAI Wed Aug 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1099319 (VAI Fri Aug 09 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1007267 (NAI Mon Jan 23 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 857252 (NAI Fri Nov 08 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 756483 (VAI Wed Nov 02 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
141921 CFR 211.42(c)(8)Released Drug Products Area
145021 CFR 211.113(a)Procedures for non-sterile drug products
184221 CFR 211.84(d)(1)Component identity verification
194321 CFR 211.180(e)(1)Review of representative number of batches
344521 CFR 211.65(a)Equipment construction - reactive surfaces
356521 CFR 211.58Buildings not maintained in good state of repair
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action