Respironics California Inc
Form 483 issued January 15, 2016 · Carlsbad, California
- Inspection
- Nov 9, 2015 – Jan 15, 2016
- Investigators
- Joey V. Quitania· Shaquenta Y. Perkins· Virgilio F. Pacio
- Observations
- 4
- Pages
- 7
- FEI number
- 3002470603
In short: On January 15, 2016, FDA issued a Form 483 with 4 observations to Respironics California Inc in Carlsbad, California (FEI 3002470603) after an inspection that ran Nov 9, 2015 – Jan 15, 2016. The investigators were Joey V. Quitania, Shaquenta Y. Perkins and Virgilio F. Pacio. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
4 of 4 observations on this 483 concern capa.
Most cited: 21 CFR 820.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Risk analysis is…
- 02
A correction or removal, conducted to reduce a risk to health posed by a device, was…
- 03
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 04
Procedures for corrective and preventive action have…
This inspection in context
Joey V. Quitania
23 documents · 2009–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmRespironics California 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 820.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Respironics California Inc?
FDA listed 4 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Respironics California Inc?
Joey V. Quitania, Shaquenta Y. Perkins and Virgilio F. Pacio are named on this Form 483, for the inspection of Nov 9, 2015 – Jan 15, 2016. Each investigator has a profile showing what they cite most.
When was Respironics California Inc inspected by FDA?
The inspection ran Nov 9, 2015 – Jan 15, 2016, and the Form 483 is dated January 15, 2016.
How do I get the full Form 483 for Respironics California 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.