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Form 483

Empire Medical Practice, PC d.b.a Kindbody Form 483, 2021-09-03

FDA issued a Form 483 to Empire Medical Practice, PC d.b.a Kindbody on 2021-09-03 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

Empire Medical Practice, PC d.b.a Kindbody · New York, United States · Issued September 3, 2021

Overview

  • 3 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.

3 Sep 2021
21 CFR 1271.50(a)

Determination based on screening and testing

Cited by Irina Gaberman

3 Sep 2021
21 CFR 1271.50(a)

Determination based on screening and testing

Cited by Irina Gaberman

3 Sep 2021
21 CFR 1271.50(a)

Determination based on screening and testing

Cited by Irina Gaberman

Inspected site

EMEmpire Medical Practice, PC d.b.a KindbodyNew York, United States

Inspection team

IGIrina Gaberman

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.50(a)Cited across public-safe Form 483 observations3x

Source document

PDF
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Form 483 source document

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Full 483 report

Get the verbatim text of all 3 observations

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