Zoll Lifecor Corporation
Form 483 issued June 20, 2014 · Pittsburgh, Pennsylvania
- Inspection
- May 22 – Jun 20, 2014
- Investigators
- Dennis R. Hock· Katelyn A. Staub-Zamperini· Katelyn A. Staub-Zaroperini
- Observations
- 3
- Pages
- 5
- FEI number
- 3008642652
In short: On June 20, 2014, FDA issued a Form 483 with 3 observations to Zoll Lifecor Corporation in Pittsburgh, Pennsylvania (FEI 3008642652) after an inspection that ran May 22 – Jun 20, 2014. The investigators were Dennis R. Hock, Katelyn A. Staub-Zamperini and Katelyn A. Staub-Zaroperini. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?).
At a glance
Observations span 1 system, led by capa.
Most cited: 21 CFR 803.50(a)(2) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Complaint Report Form with Call Report# (b) (4) documents that a 76 year old patient received…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Complaint Report Form with Call Report#(b) (4)(b) (4) documents that on 04/26/2014, a 68 year old…
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 firmZoll Lifecor Corporation history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 803.50(a)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zoll Lifecor Corporation?
FDA listed 3 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?). The opening words of each observation are shown on this page.
Who inspected Zoll Lifecor Corporation?
Dennis R. Hock, Katelyn A. Staub-Zamperini and Katelyn A. Staub-Zaroperini are named on this Form 483, for the inspection of May 22 – Jun 20, 2014. Each investigator has a profile showing what they cite most.
When was Zoll Lifecor Corporation inspected by FDA?
The inspection ran May 22 – Jun 20, 2014, and the Form 483 is dated June 20, 2014.
How do I get the full Form 483 for Zoll Lifecor Corporation?
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.