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Form 483

Advanced Monitored Caregiving, Inc. Form 483, 2020-11-12

FDA issued a Form 483 to Advanced Monitored Caregiving, Inc. on 2020-11-12 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Advanced Monitored Caregiving, Inc. · New York, United States · Issued November 12, 2020

Overview

  • 2 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

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

Inspected site

AMAdvanced Monitored Caregiving, Inc.New York, United States

Inspection team

KPKwong P Lee

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations2x

Source document

PDF
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Form 483 source document

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Full 483 report

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The source PDF, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere