Innovative Surgical Solutions, LLC
Form 483 issued May 20, 2015 · Wixom, Michigan
- Inspection
- May 12 – May 20, 2015
- Investigator
- Deanna L. Lampley
- Observations
- 2
- Pages
- 2
- FEI number
- 3009274855
In short: On May 20, 2015, FDA issued a Form 483 with 2 observations to Innovative Surgical Solutions, LLC in Wixom, Michigan (FEI 3009274855) after an inspection that ran May 12 – May 20, 2015. The investigator was Deanna L. Lampley. Most observations concern design controls and cAPA; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and capa account for 2 of 2 observations.
Most cited: 21 CFR 820.30(e) (1×) · 806.20(b)(4) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The design review results, including identification of the design, the date, and the individual(s) performing the…
- 02
A justification for not reporting the correction or removal action to FDA that included conclusions, follow-ups…
This inspection in context
Deanna L. Lampley
2 documents · 2015
Cites 820.184 (device history record) more than any other section. Most of their documents are for sites in Michigan.
The firmInnovative Surgical Solutions, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Innovative Surgical Solutions, LLC?
FDA listed 2 observations on this Form 483, mostly about design controls and cAPA. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Innovative Surgical Solutions, LLC?
Deanna L. Lampley is named on this Form 483, for the inspection of May 12 – May 20, 2015. Each investigator has a profile showing what they cite most.
When was Innovative Surgical Solutions, LLC inspected by FDA?
The inspection ran May 12 – May 20, 2015, and the Form 483 is dated May 20, 2015.
How do I get the full Form 483 for Innovative Surgical Solutions, 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.