Respironics, Inc
Form 483 issued February 14, 2023 · Mount Pleasant, Pennsylvania
- Inspection
- Jan 25 – Feb 14, 2023
- Investigator
- Dennis R. Hock
- Observations
- 1
- Pages
- 4
- FEI number
- 3002797442
In short: On February 14, 2023, FDA issued a Form 483 with 1 observation to Respironics, Inc in Mount Pleasant, Pennsylvania (FEI 3002797442) after an inspection that ran Jan 25 – Feb 14, 2023. The investigator was Dennis R. Hock. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
1 of 1 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.75(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
This inspection in context
Dennis R. Hock
10 documents · 2014–2024
Cites 820.30(g) (design controls) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmRespironics, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Respironics, Inc?
FDA listed 1 observation on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected Respironics, Inc?
Dennis R. Hock is named on this Form 483, for the inspection of Jan 25 – Feb 14, 2023. Each investigator has a profile showing what they cite most.
When was Respironics, Inc inspected by FDA?
The inspection ran Jan 25 – Feb 14, 2023, and the Form 483 is dated February 14, 2023.
How do I get the full Form 483 for 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.