Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 1832562.
Observations1
Issue DateApril 22, 2025
StatusNo Warning Letter
Related Inspections5
Establishment Details
Firm
Pulmodyne Inc.
Location
Indianapolis, Indiana, United States
FEI Number
1832562
Product Type
Devices
Issue Date
April 22, 2025
Country
United States
Inspection History, 2010 to 2025
NAI1
VAI3
OAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.