Advanced Monitored Caregiving
Form 483 issued November 12, 2020 · New York, New York
- Inspection
- Oct 29 – Nov 12, 2020
- Investigator
- Kwong P. Lee
- Observations
- 1
- Pages
- 2
- FEI number
- 3005439460
In short: On November 12, 2020, FDA issued a Form 483 with 1 observation to Advanced Monitored Caregiving in New York, New York (FEI 3005439460) after an inspection that ran Oct 29 – Nov 12, 2020. The investigator was Kwong P. Lee. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.17 (what are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 803.17 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written MDR procedures have not…
This inspection in context
Kwong P. Lee
12 documents · 2015–2026
Cites 820.30(c) (design controls) 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 803.17
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Advanced Monitored Caregiving?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.17 (what are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?). The opening words of each observation are shown on this page.
Who inspected Advanced Monitored Caregiving?
Kwong P. Lee is named on this Form 483, for the inspection of Oct 29 – Nov 12, 2020. Each investigator has a profile showing what they cite most.
When was Advanced Monitored Caregiving inspected by FDA?
The inspection ran Oct 29 – Nov 12, 2020, and the Form 483 is dated November 12, 2020.
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.