Zoll Medical Corporations
Form 483 issued March 10, 2022 · Rumford, Rhode Island
- Inspection
- Mar 3 – Mar 10, 2022
- Investigator
- Maryam Tabatabaie
- Observations
- 4
- Pages
- 5
- FEI number
- 3017267612
In short: On March 10, 2022, FDA issued a Form 483 with 4 observations to Zoll Medical Corporations in Rumford, Rhode Island (FEI 3017267612) after an inspection that ran Mar 3 – Mar 10, 2022. The investigator was Maryam Tabatabaie. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
3 of 4 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.75 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
A validated process was not reviewed and evaluated and revalidated when changes…
- 03
Procediues have not been adequately established to control product that does not…
- 04
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
This inspection in context
Maryam Tabatabaie
11 documents · 2016–2024
Cites 820.198 (complaint files) more than any other section. Most of their documents are for sites in Rhode Island.
The firmZoll Medical Corporations history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zoll Medical Corporations?
FDA listed 4 observations on this Form 483, mostly about production & process controls and cAPA. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected Zoll Medical Corporations?
Maryam Tabatabaie is named on this Form 483, for the inspection of Mar 3 – Mar 10, 2022. Each investigator has a profile showing what they cite most.
When was Zoll Medical Corporations inspected by FDA?
The inspection ran Mar 3 – Mar 10, 2022, and the Form 483 is dated March 10, 2022.
How do I get the full Form 483 for Zoll Medical Corporations?
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.