Philips Respironics, Inc.
Form 483 issued November 9, 2021 · Murrysville, Pennsylvania
- Inspection
- Aug 26 – Nov 9, 2021
- Investigator
- Katelyn A. Staub-Zamperini
- Observations
- 8
- Pages
- 29
- FEI number
- 2518422
In short: On November 9, 2021, FDA issued a Form 483 with 8 observations to Philips Respironics, Inc. in Murrysville, Pennsylvania (FEI 2518422) after an inspection that ran Aug 26 – Nov 9, 2021. The investigator was Katelyn A. Staub-Zamperini. Most observations concern design controls and cAPA; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and capa account for 5 of 8 observations.
Most cited: 21 CFR 820.30(g) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Risk analysis is…
- 02
Procedmes for conective and preventive action have…
- 03
Design validation did not ensure the device conforms to defined user…
- 04
Procedmes for design change have…
This inspection in context
Katelyn A. Staub-Zamperini
7 documents · 2014–2024
Cites 820.30(g) (design controls) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmPhilips Respironics, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Philips Respironics, Inc.?
FDA listed 8 observations on this Form 483, mostly about design controls, cAPA and production & process controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Philips Respironics, Inc.?
Katelyn A. Staub-Zamperini is named on this Form 483, for the inspection of Aug 26 – Nov 9, 2021. Each investigator has a profile showing what they cite most.
When was Philips Respironics, Inc. inspected by FDA?
The inspection ran Aug 26 – Nov 9, 2021, and the Form 483 is dated November 9, 2021.
How do I get the full Form 483 for Philips Respironics, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.