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FDA Warning Letter — HTO Nevada Inc. dba Kirkman

Case 719074 — FEI 3004268965

The FDA took a Warning Letter action against HTO Nevada Inc. dba Kirkman on January 27, 2026 (Lake Oswego, OR). The action was issued by CDER and concerns drugs products. This facility has 5 or more recent FDA inspections on record.

Action Details

Facility
HTO Nevada Inc. dba Kirkman
Date
January 27, 2026
Fiscal Year
2026
Product Type
Drugs
Center
CDER
Location
Lake Oswego, OR (United States)

Facility

Recent inspections

  • 1279218 (OAI Fri Aug 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1216435 (VAI Thu Aug 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1083505 (VAI Fri Mar 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1065834 (NAI Mon Apr 02 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1010178 (VAI Fri Apr 14 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Other compliance actions

FDA data resources