Surgitech Inc
Form 483 issued August 10, 2023 · Carlsbad, California
- Inspection
- Aug 8 – Aug 10, 2023
- Investigator
- Ebony D. Sanon
- Observations
- 10
- Pages
- 8
- FEI number
- 3004014634
In short: On August 10, 2023, FDA issued a Form 483 with 10 observations to Surgitech Inc in Carlsbad, California (FEI 3004014634) after an inspection that ran Aug 8 – Aug 10, 2023. The investigator was Ebony D. Sanon. Most observations concern cAPA and management controls.
At a glance
CAPA and management controls account for 6 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
Design plans were not reviewed and approved as…
- 02
A device history record has…
- 03
Procedures for corrective and preventive action have…
- 04
Complaint files are not…
This inspection in context
Ebony D. Sanon
8 documents · 2022–2026
Cites 820.184 (device history record) more than any other section. Most of their documents are for sites in Florida.
The firmSurgitech Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Surgitech Inc?
FDA listed 10 observations on this Form 483, mostly about cAPA, management controls and production & process controls. The opening words of each observation are shown on this page.
Who inspected Surgitech Inc?
Ebony D. Sanon is named on this Form 483, for the inspection of Aug 8 – Aug 10, 2023. Each investigator has a profile showing what they cite most.
When was Surgitech Inc inspected by FDA?
The inspection ran Aug 8 – Aug 10, 2023, and the Form 483 is dated August 10, 2023.
How do I get the full Form 483 for Surgitech 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.