Atlas

FDA-Inspected Site

Advanced Monitored Caregiving, Inc.

7 FDA inspections are on record for Advanced Monitored Caregiving, Inc. in New York, United States.

483· Form 483 issued

New York, United States · Last updated August 15, 2026

Overview

  • 7 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-01-31.

At a glance

Inspections

7

Form 483s

6

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
13 Jan 2025 – 31 Jan 2025Medical Devices & Rad Health483View 483 →
29 Oct 2020 – 12 Nov 2020Medical Devices & Rad Health483View 483 →
22 Mar 2018 – 29 Mar 2018Medical Devices & Rad Health483View 483 →
26 Jan 2015 – 28 Jan 2015Medical Devices & Rad HealthClean
20 Feb 2013 – 22 Feb 2013Medical Devices & Rad Health483View 483 →
13 Dec 2011Not recorded483View 483 →
11 Dec 2009Not recorded483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

31 Jan 2025
21 CFR 806.20(b)(4)

Justification for not reporting

Cited by Jacqueline S Warner

31 Jan 2025
21 CFR 820.198(b)

Review and evaluation for investigation

Cited by Jacqueline S Warner

31 Jan 2025
21 CFR 820.30(j)

Design history file

Cited by Jacqueline S Warner

12 Nov 2020
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Kwong P Lee

12 Nov 2020
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Kwong P Lee

Investigators

FDA investigators tied to this site in the record.

Ronald Ifraimov3 insp.
Jacqueline S Warner1 insp.
Kwong P Lee1 insp.
Andrew J Garufi1 insp.
Stephanie Durso1 insp.
Matthew R Palo1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.20(c)Cited across public-safe Form 483 observations4x
21 CFR 820.50(a)(1)Cited across public-safe Form 483 observations3x
21 CFR 820.80(a)Cited across public-safe Form 483 observations3x
21 CFR 803.17Cited across public-safe Form 483 observations2x
21 CFR 820.100(a)Cited across public-safe Form 483 observations2x
21 CFR 820.184Cited across public-safe Form 483 observations2x
21 CFR 820.22Cited across public-safe Form 483 observations2x
21 CFR 820.30(a)Cited across public-safe Form 483 observations2x
21 CFR 820.30(i)Cited across public-safe Form 483 observations2x
21 CFR 820.80(d)Cited across public-safe Form 483 observations2x
21 CFR 820.80(e)Cited across public-safe Form 483 observations2x
21 CFR 820.90(a)Cited across public-safe Form 483 observations2x
21 CFR 806.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 820.181(a)Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.198(b)Cited across public-safe Form 483 observations1x
21 CFR 820.20(a)Cited across public-safe Form 483 observations1x
21 CFR 820.20(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 820.20(d)Cited across public-safe Form 483 observations1x
21 CFR 820.25(b)Cited across public-safe Form 483 observations1x
21 CFR 820.30(g)Cited across public-safe Form 483 observations1x
21 CFR 820.30(j)Cited across public-safe Form 483 observations1x
21 CFR 820.40Cited across public-safe Form 483 observations1x
21 CFR 820.40(a)Cited across public-safe Form 483 observations1x
21 CFR 820.50(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 820.50(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Advanced Monitored Caregiving, Inc.'s 6 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat