Forge Medical Inc
Form 483 issued July 18, 2018 · Bethlehem, Pennsylvania
- Inspection
- Jul 3 – Jul 18, 2018
- Investigator
- Edward D. McDonald
- Observations
- 5
- Pages
- 4
- FEI number
- 3009595977
In short: On July 18, 2018, FDA issued a Form 483 with 5 observations to Forge Medical Inc in Bethlehem, Pennsylvania (FEI 3009595977) after an inspection that ran Jul 3 – Jul 18, 2018. The investigator was Edward D. McDonald. Most observations concern production & process controls and records & documents.
At a glance
Production & process controls and records & documents account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for changes to a specification and process have…
- 02
A device master record…
- 03
Corrective and preventive action activities and/or results have…
- 04
Personnel training is not…
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 firmForge Medical Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.70(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Forge Medical Inc?
FDA listed 5 observations on this Form 483, mostly about production & process controls, records & documents and cAPA. The opening words of each observation are shown on this page.
Who inspected Forge Medical Inc?
Edward D. McDonald is named on this Form 483, for the inspection of Jul 3 – Jul 18, 2018. Each investigator has a profile showing what they cite most.
When was Forge Medical Inc inspected by FDA?
The inspection ran Jul 3 – Jul 18, 2018, and the Form 483 is dated July 18, 2018.
How do I get the full Form 483 for Forge Medical 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.