Accurate Surgical & Scientific
Form 483 issued July 18, 2018 · Westbury, New York
- Inspection
- Jul 17 – Jul 18, 2018
- Investigator
- Andrew Garufi
- Observations
- 1
- Pages
- 3
- FEI number
- 2434839
In short: On July 18, 2018, FDA issued a Form 483 with 1 observation to Accurate Surgical & Scientific in Westbury, New York (FEI 2434839) after an inspection that ran Jul 17 – Jul 18, 2018. The investigator was Andrew Garufi. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.50 (purchasing controls).
At a glance
1 of 1 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.50(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Requirements that must be met by suppliers, contractors and consultants…
This inspection in context
Andrew Garufi
11 documents · 2015–2025
Cites 820.80(b) (receiving, in-process, and finished device acceptance) more than any other section. Most of their documents are for sites in New York.
The firmAccurate Surgical & Scientific history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.50(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Accurate Surgical & Scientific?
FDA listed 1 observation on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.50 (purchasing controls). The opening words of each observation are shown on this page.
Who inspected Accurate Surgical & Scientific?
Andrew Garufi is named on this Form 483, for the inspection of Jul 17 – Jul 18, 2018. Each investigator has a profile showing what they cite most.
When was Accurate Surgical & Scientific inspected by FDA?
The inspection ran Jul 17 – Jul 18, 2018, and the Form 483 is dated July 18, 2018.
How do I get the full Form 483 for Accurate Surgical & Scientific?
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.