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FDA Inspection 1298980 — Klarity Medical Products LLC

Klarity Medical Products LLC — FEI 3001236129

The FDA completed an inspection of Klarity Medical Products LLC on May 20, 2026 in Heath, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 20, 2026
Fiscal Year
2026
Product Type
Devices
Project Area
Compliance: Devices
Location
Heath, OH (United States)

Citations

IDCFRDescription
23135ISO 13485:2016 Clause 7.3.9Records of design and development changes and their reviews not maintained
23145ISO 13485:2016 Clause 7.4.1Records of supplier (re)evaluation, selection, and monitoring not maintained
23169ISO 13485:2016 Clause 7.5.6Procedures for validation of processes not documented
23247ISO 13485:2016 Clause 8.3.4Reworked product not verified

Facility

Other inspections at this facility

  • 1198362 (VAI Thu Feb 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1148020 (VAI Fri Jul 09 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1119795 (OAI Tue Feb 25 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 991292 (NAI Tue Nov 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 850009 (VAI Mon Sep 30 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources