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Form 483

Allstar Marketing Group Llc Form 483, 2022-03-21

FDA issued a Form 483 to Allstar Marketing Group Llc on 2022-03-21 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

Allstar Marketing Group Llc · Hawthorne, United States · Issued March 21, 2022

Overview

  • 4 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.

21 Mar 2022
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Kwong P Lee

21 Mar 2022
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Kwong P Lee

21 Mar 2022
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Kwong P Lee

21 Mar 2022
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Kwong P Lee

Inspected site

AMAllstar Marketing Group LlcHawthorne, 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 observations4x

Source document

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Form 483 source document

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Full 483 report

Get the verbatim text of all 4 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