MicroSurgical Technology, Inc.
Form 483 issued October 16, 2015 · Redmond, Washington
- Inspection
- Oct 5 – Oct 16, 2015
- Investigator
- Cynthia L. Gorveatt
- Observations
- 2
- Pages
- 2
- FEI number
- 3019924
In short: On October 16, 2015, FDA issued a Form 483 with 2 observations to MicroSurgical Technology, Inc. in Redmond, Washington (FEI 3019924) after an inspection that ran Oct 5 – Oct 16, 2015. The investigator was Cynthia L. Gorveatt. Most observations concern design controls and records & documents; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and records & documents account for 2 of 2 observations.
Most cited: 21 CFR 820.30(i) (1×) · 820.40 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design change have…
- 02
Document control procedures have…
This inspection in context
Cynthia L. Gorveatt
2 documents · 2015–2016
Cites 820.30(c) (design controls) more than any other section. Most of their documents are for sites in Washington.
The firmMicroSurgical Technology, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(i)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MicroSurgical Technology, Inc.?
FDA listed 2 observations on this Form 483, mostly about design controls and records & documents. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected MicroSurgical Technology, Inc.?
Cynthia L. Gorveatt is named on this Form 483, for the inspection of Oct 5 – Oct 16, 2015. Each investigator has a profile showing what they cite most.
When was MicroSurgical Technology, Inc. inspected by FDA?
The inspection ran Oct 5 – Oct 16, 2015, and the Form 483 is dated October 16, 2015.
How do I get the full Form 483 for MicroSurgical Technology, 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.