Company
United StatesRespironics, Inc., Mount Pleasant, PA – FDA Inspections
Inspection records and compliance data for Respironics, Inc. in Mount Pleasant, Pennsylvania. 3 FDA inspections on record (1 OAI), 1 Form 483, last inspected February 14, 2023.
Company Profile
This profile covers Respironics, Inc. based in Mount Pleasant, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 0
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected September 1, 2010. Last inspected February 14, 2023.
Most cited issue areas
- Lack of or inadequate process validation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 14, 2023 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1197512 |
| December 7, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 996159 |
| September 1, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 678515 |
FDA documents
Form 483s (1)
EIRs (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Respironics, Inc.
FEI Number
3002797442
Address
174 Tech Center Dr, Mount Pleasant, Pennsylvania 15666, United States
Country
United States
ID: c83d367f-6fcb-4662-9e60-64367f76051e