Advanced Monitored Caregiving
Form 483 issued March 29, 2018 · New York, New York
- Inspection
- Mar 22 – Mar 29, 2018
- Investigator
- Andrew Garufi
- Observations
- 4
- Pages
- 4
- FEI number
- 3005439460
In short: On March 29, 2018, FDA issued a Form 483 with 4 observations to Advanced Monitored Caregiving in New York, New York (FEI 3005439460) after an inspection that ran Mar 22 – Mar 29, 2018. The investigator was Andrew Garufi. Most observations concern production & process controls and design controls; the most-cited regulation is 21 CFR 820.80 (receiving, in-process, and finished device acceptance).
At a glance
3 of 4 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for finished device acceptance have…
- 02
Acceptance activities were not…
- 03
The evaluation of potential…
- 04
Procedures for design change have…
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 firmAdvanced Monitored Caregiving history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.80(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Advanced Monitored Caregiving?
FDA listed 4 observations on this Form 483, mostly about production & process controls and design controls. The most-cited regulation is 21 CFR 820.80 (receiving, in-process, and finished device acceptance). The opening words of each observation are shown on this page.
Who inspected Advanced Monitored Caregiving?
Andrew Garufi is named on this Form 483, for the inspection of Mar 22 – Mar 29, 2018. Each investigator has a profile showing what they cite most.
When was Advanced Monitored Caregiving inspected by FDA?
The inspection ran Mar 22 – Mar 29, 2018, and the Form 483 is dated March 29, 2018.
How do I get the full Form 483 for Advanced Monitored Caregiving?
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.