Synovo Production, Inc
Form 483 issued October 26, 2022 · Fullerton, California
- Inspection
- Oct 11 – Oct 26, 2022
- Investigator
- Kevin N. Tran
- Observations
- 7
- Pages
- 6
- FEI number
- 3022090924
In short: On October 26, 2022, FDA issued a Form 483 with 7 observations to Synovo Production, Inc in Fullerton, California (FEI 3022090924) after an inspection that ran Oct 11 – Oct 26, 2022. The investigator was Kevin N. Tran. Most observations concern management controls and production & process controls.
At a glance
Management controls and production & process controls account for 5 of 7 observations.
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
Procedures for design change have…
- 03
Procedures for corrective and preventive action have…
- 04
The evaluation of potential…
This inspection in context
Kevin N. Tran
7 documents · 2019–2025
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in California.
The firmSynovo Production, Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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 Synovo Production, Inc?
FDA listed 7 observations on this Form 483, mostly about management controls, production & process controls and design controls. The opening words of each observation are shown on this page.
Who inspected Synovo Production, Inc?
Kevin N. Tran is named on this Form 483, for the inspection of Oct 11 – Oct 26, 2022. Each investigator has a profile showing what they cite most.
When was Synovo Production, Inc inspected by FDA?
The inspection ran Oct 11 – Oct 26, 2022, and the Form 483 is dated October 26, 2022.
How do I get the full Form 483 for Synovo Production, 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.