Synovo Production, Inc
Form 483 issued October 2, 2023 · Fullerton, California
- Inspection
- Sep 8 – Oct 2, 2023
- Investigator
- Kevin N. Tran
- Observations
- 5
- Pages
- 5
- FEI number
- 3022090924
In short: On October 2, 2023, FDA issued a Form 483 with 5 observations to Synovo Production, Inc in Fullerton, California (FEI 3022090924) after an inspection that ran Sep 8 – Oct 2, 2023. The investigator was Kevin N. Tran. Most observations concern production & process controls and design controls.
At a glance
Production & process controls and design controls account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Process validation activities have…
- 02
The design history file…
- 03
Corrective and preventive action activities and/or results have…
- 04
Potential suppliers were not evaluated based on their- ability…
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 5 observations on this Form 483, mostly about production & process controls, design controls and cAPA. 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 Sep 8 – Oct 2, 2023. Each investigator has a profile showing what they cite most.
When was Synovo Production, Inc inspected by FDA?
The inspection ran Sep 8 – Oct 2, 2023, and the Form 483 is dated October 2, 2023.
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.