Philips Respironics, Inc.
FDA inspection history in Murrysville, Pennsylvania, 2015 to 2021
- 2
- Close-outs
- 1
- Form 483
Every document, by year
- Form 483
- Close-out
2015: two close-out letters; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015Two close-out letters, at Murrysville, Pennsylvania.
- 2021One Form 483, at Murrysville, Pennsylvania.
Cited most
Across all Philips Respironics observations on file
- 21 CFR 820.30(g)Design controls3
- 21 CFR 820.50Purchasing controls2
- 21 CFR 806.10(a)(1)Reports of corrections and removals1
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.20(a)Management responsibility1
The complete Philips Respironics file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Murrysville, Pennsylvania
Two close-out letters and one Form 483 · 2015 to 2021 · 8 observations
Latest: Form 483, Nov 9, 2021 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-11-09 | 483 Form 483 | Murrysville, Pennsylvania | 8 | $99 |
| 2015-03-04 | Close-out Close-out letter | Murrysville, Pennsylvania | — | $99 |
| 2015-03-04 | Close-out Close-out letter | Murrysville, Pennsylvania | — | $99 |
Investigators on these documents
FEI number 2518422 · most recent document Nov 9, 2021
About Philips Respironics, Inc.
How many FDA Form 483s has Philips Respironics, Inc. received?
FDA Intel has 1 Form 483 on file for Philips Respironics, Inc.; the most recent is dated Nov 9, 2021.
When was Philips Respironics, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Philips Respironics, Inc. is a Form 483 dated Nov 9, 2021, for the site in Murrysville, Pennsylvania.
What did FDA cite at Philips Respironics, Inc.?
The regulations cited most in the observations on file for Philips Respironics, Inc. are 21 CFR 820.30(g) (Design controls), 3 times; 21 CFR 820.50 (Purchasing controls), 2 times; 21 CFR 806.10(a)(1) (Reports of corrections and removals), 1 time.