Atlas

Form 483

General Marketing Solutions LLC Form 483, 2019-11-08

FDA issued a Form 483 to General Marketing Solutions LLC on 2019-11-08 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

General Marketing Solutions LLC · Key Biscayne, United States · Issued November 8, 2019

Overview

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

Inspectional observations

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

8 Nov 2019
21 CFR 111.140(b)(1)

QC ops; written procedures; material review, disposition

Cited by John J Bernal

8 Nov 2019
21 CFR 111.503

Written procedures - returned dietary supplement

Cited by John J Bernal

8 Nov 2019
21 CFR 111.75(a)(2)(ii)(A)

Component - qualify supplier

Cited by John J Bernal

8 Nov 2019
21 CFR 111.503

Written procedures - returned dietary supplement

Cited by John J Bernal

8 Nov 2019
21 CFR 111.75(a)(2)(ii)(A)

Component - qualify supplier

Cited by John J Bernal

Inspected site

GMGeneral Marketing Solutions LLCKey Biscayne, United States

Inspection team

JJJohn J Bernal

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.503Cited across public-safe Form 483 observations2x
21 CFR 111.75(a)(2)(ii)(A)Cited across public-safe Form 483 observations2x
21 CFR 111.140(b)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 observations

Every observation in full, 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