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FDA Inspection 1310200 — MP Biomedicals Diagnostics Division

MP Biomedicals Diagnostics Division — FEI 2419955

The FDA completed an inspection of MP Biomedicals Diagnostics Division on March 31, 2026 in Solon, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 31, 2026
Fiscal Year
2026
Product Type
Devices
Project Area
Compliance: Devices
Location
Solon, OH (United States)

Citations

IDCFRDescription
23087ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
23138ISO 13485:2016 Clause 7.4.1Procedures for purchasing process not documented
23194ISO 13485:2016 Clause 7.6(a)Measuring equipment not adequately calibrated or verified

Facility

Other inspections at this facility

  • 1034831 (VAI Wed Dec 13 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 760696 (NAI Thu Dec 15 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 657363 (OAI Thu Apr 22 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources