Stoner Incorporated
Form 483 issued November 15, 2023 · Quarryville, Pennsylvania
- Inspection
- Nov 7 – Nov 15, 2023
- Investigator
- Edward D. McDonald
- Observations
- 2
- Pages
- 4
- FEI number
- 3000538043
In short: On November 15, 2023, FDA issued a Form 483 with 2 observations to Stoner Incorporated in Quarryville, Pennsylvania (FEI 3000538043) after an inspection that ran Nov 7 – Nov 15, 2023. The investigator was Edward D. McDonald. Most observations concern records & documents and management controls; the most-cited regulation is 21 CFR 820.181 (device master record).
At a glance
Records & documents and management controls account for 2 of 2 observations.
Most cited: 21 CFR 820.181 (1×) · 820.20(b)(3)(i) (1×)
What FDA observed
Preview: the opening words of each observation- 01
A device master record…
- 02
The management representative has not ensured that the quality system requirements are…
This inspection in context
Edward D. McDonald
8 documents · 2014–2026
Cites 820.20 (management responsibility) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmStoner Incorporated history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.181
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Stoner Incorporated?
FDA listed 2 observations on this Form 483, mostly about records & documents and management controls. The most-cited regulation is 21 CFR 820.181 (device master record). The opening words of each observation are shown on this page.
Who inspected Stoner Incorporated?
Edward D. McDonald is named on this Form 483, for the inspection of Nov 7 – Nov 15, 2023. Each investigator has a profile showing what they cite most.
When was Stoner Incorporated inspected by FDA?
The inspection ran Nov 7 – Nov 15, 2023, and the Form 483 is dated November 15, 2023.
How do I get the full Form 483 for Stoner Incorporated?
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.