Johnson Medtech LLC
Form 483 issued December 8, 2022 · Vandalia, Ohio
- Inspection
- Nov 17 – Dec 8, 2022
- Investigator
- Rosanna M. Goodrich
- Observations
- 6
- Pages
- 7
- FEI number
- 3013522941
In short: On December 8, 2022, FDA issued a Form 483 with 6 observations to Johnson Medtech LLC in Vandalia, Ohio (FEI 3013522941) after an inspection that ran Nov 17 – Dec 8, 2022. The investigator was Rosanna M. Goodrich. Most observations concern production & process controls and cAPA.
At a glance
Production & process controls and capa account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Procedures for corrective and preventive action have…
- 03
The acceptance status of…
- 04
Production processes were not controlled to ensure that a device…
This inspection in context
Rosanna M. Goodrich
13 documents · 2015–2025
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Ohio.
The firmJohnson Medtech LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Johnson Medtech LLC?
FDA listed 6 observations on this Form 483, mostly about production & process controls, cAPA and records & documents. The opening words of each observation are shown on this page.
Who inspected Johnson Medtech LLC?
Rosanna M. Goodrich is named on this Form 483, for the inspection of Nov 17 – Dec 8, 2022. Each investigator has a profile showing what they cite most.
When was Johnson Medtech LLC inspected by FDA?
The inspection ran Nov 17 – Dec 8, 2022, and the Form 483 is dated December 8, 2022.
How do I get the full Form 483 for Johnson Medtech LLC?
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.