Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 2518422.
Observations14
Issue DateNovember 09, 2021
StatusNo Warning Letter
Establishment TypeMedical Device Manufacturer
Related Inspections10
Establishment Details
Firm
Philips Respironics, Inc.
Location
Murrysville, Pennsylvania, United States
FEI Number
2518422
Establishment Type
Medical Device Manufacturer
Product Type
Devices
Issue Date
November 09, 2021
Country
United States
Inspection History, 2014 to 2022
NAI3
VAI2
OAI5
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.