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612736

MYA International, Inc — FEI 3002820512

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 18, 2009
Fiscal Year
2009
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Chula Vista, CA (United States)

Facility

Other inspections at this facility

  • 1175136 (VAI Fri Jul 22 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1151805 (OAI Fri Sep 10 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1014478 (OAI Fri Jun 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 925671 (VAI Wed May 13 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 756691 (VAI Mon Dec 12 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
116221 CFR 211.28(a)Protective Apparel Not Worn
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
121521 CFR 211.67(b)Written procedures not established/followed
178721 CFR 211.80(a)Procedures To Be in Writing
358221 CFR 211.105(a)Identification of containers, lines, equipment
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
437621 CFR 211.188(b)(4)Weights and measures of components used