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Form 483

Berman, Gary D., MD, Clinical Investigator Form 483, 2021-03-29

FDA issued a Form 483 to Berman, Gary D., MD, Clinical Investigator on 2021-03-29 with 1 public-safe observation.

483· Form 483 issuedBiologics1 observation

Berman, Gary D., MD, Clinical Investigator · Minneapolis, United States · Issued March 29, 2021

Overview

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

Inspectional observations

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

29 Mar 2021
21 CFR 312.60

FD-1572, protocol compliance

Cited by Nicole C Victoria, Sharon L Matson

Inspected site

BGBerman, Gary D., MD, Clinical InvestigatorMinneapolis, United States

Inspection team

NCNicole C Victoria
SLSharon L Matson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.60Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

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Full 483 report

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  • 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