Flex Operating Room, LLC
Form 483 issued June 18, 2019 · Pittsford, New York
- Inspection
- Jun 12 – Jun 18, 2019
- Investigator
- Matthew D. Schnittker
- Observations
- 3
- Pages
- 6
- FEI number
- 3012966700
In short: On June 18, 2019, FDA issued a Form 483 with 3 observations to Flex Operating Room, LLC in Pittsford, New York (FEI 3012966700) after an inspection that ran Jun 12 – Jun 18, 2019. The investigator was Matthew D. Schnittker. Most observations concern design controls and production & process controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
2 of 3 observations on this 483 concern design controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design control…
- 0221 CFR 820.30(j)21 CFR 820
The design history file…
- 03
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
This inspection in context
Matthew D. Schnittker
12 documents · 2015–2025
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in New York.
The firmFlex Operating Room, 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 Flex Operating Room, LLC?
FDA listed 3 observations on this Form 483, mostly about design controls and production & process controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Flex Operating Room, LLC?
Matthew D. Schnittker is named on this Form 483, for the inspection of Jun 12 – Jun 18, 2019. Each investigator has a profile showing what they cite most.
When was Flex Operating Room, LLC inspected by FDA?
The inspection ran Jun 12 – Jun 18, 2019, and the Form 483 is dated June 18, 2019.
How do I get the full Form 483 for Flex Operating Room, 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.