Device establishmentActive, RegisteredFDA warning letter on file
DeVilbiss Healthcare LLC.
DeVilbiss Healthcare LLC. is an FDA-registered device establishment (FEI 2515872) located in SOMERSET, Pennsylvania. The facility is active, registered. Its most recent FDA inspection on record (2024-05-30) was classified NAI. FDA has issued 1 warning letter(s) to this facility.
FDA warning letter
A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.
Establishment record
Inspection history
Aug 17, 2022 · Official Action Indicated (OAI)
Aug 25, 2021 · Official Action Indicated (OAI)
Jan 28, 2016 · No Action Indicated (NAI)
Feb 22, 2012 · No Action Indicated (NAI)
Mar 31, 2010 · No Action Indicated (NAI)
Apr 15, 2009 · No Action Indicated (NAI)
Aug 25, 2021, 9 observations: Lack of or inadequate procedures; Lack of System for Event Evaluations; Design verification - output does not meet input requirement
FDA record timeline
Combined chronology of the public records shown on this page. FDA coverage varies by dataset and year.
Questions
Is DeVilbiss Healthcare LLC. registered with the FDA?
Yes. DeVilbiss Healthcare LLC. is an FDA-registered device establishment (FEI 2515872) in SOMERSET, Pennsylvania. Its current registration status is Active, Registered.
Has DeVilbiss Healthcare LLC. received an FDA warning letter?
Yes. FDA issued a warning letter to DeVilbiss Healthcare LLC.; the most recent is dated Nov 23, 2021 (Medical Device Reporting/Misbranded).
What does DeVilbiss Healthcare LLC. do?
DeVilbiss Healthcare LLC.'s FDA-registered operations are: Anesthesiology, Manufacture Medical Device, General Hospital, General, Plastic Surgery, Repack or Relabel Medical Device, Physical Medicine.
Related facilities
Source: FDA public data · status as of 2026-08-22