Santanello Surgical LLC
Form 483 issued June 7, 2019 · Columbus, Ohio
- Inspection
- May 30 – Jun 7, 2019
- Investigator
- Javonica F. Penn
- Observations
- 4
- Pages
- 5
- FEI number
- 3013555389
In short: On June 7, 2019, FDA issued a Form 483 with 4 observations to Santanello Surgical LLC in Columbus, Ohio (FEI 3013555389) after an inspection that ran May 30 – Jun 7, 2019. The investigator was Javonica F. Penn. Most observations concern design controls and production & process controls.
At a glance
Design controls and production & process controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design control…
- 02
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 03
Procedures for corrective and preventive action…
This inspection in context
Javonica F. Penn
4 documents · 2016–2026
Cites ISO 13485:2016 Clause 7.4.1 more than any other section. Most of their documents are for sites in Ohio.
The firmSantanello Surgical LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Santanello Surgical LLC?
FDA listed 4 observations on this Form 483, mostly about design controls, production & process controls and cAPA. The opening words of each observation are shown on this page.
Who inspected Santanello Surgical LLC?
Javonica F. Penn is named on this Form 483, for the inspection of May 30 – Jun 7, 2019. Each investigator has a profile showing what they cite most.
When was Santanello Surgical LLC inspected by FDA?
The inspection ran May 30 – Jun 7, 2019, and the Form 483 is dated June 7, 2019.
How do I get the full Form 483 for Santanello Surgical 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.