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825989

Beauty Manufacturing Solutions Corp. — FEI 1610490

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 4, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Coppell, TX (United States)

Facility

Other inspections at this facility

  • 1287184 (VAI Mon Nov 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1140508 (VAI Wed Apr 07 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1056752 (OAI Thu Jun 14 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1016639 (OAI Fri Jun 30 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 976229 (NAI Fri Feb 19 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
139321 CFR 211.103Yield calculations not verified by 2nd person
139521 CFR 211.103Actual vs. theoretical yields not determined
194321 CFR 211.180(e)(1)Review of representative number of batches
197521 CFR 211.182Written records kept in individual logs
200921 CFR 211.188Prepared for each batch, include complete information
358521 CFR 211.110(a)Control procedures to monitor and validate performance
436621 CFR 211.188(a)Accurate reproduction included
436921 CFR 211.188(b)(11)Identification of persons involved, each significant step
437221 CFR 211.188(b)(8)Labeling control records including specimens or copies
441821 CFR 211.42(b)Adequate space lacking to prevent mix-ups and contamination