Form 483

PBM Nutritionals, LLC Form 483, 2023-07-21

FDA issued a Form 483 to PBM Nutritionals, LLC on 2023-07-21 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

PBM Nutritionals, LLC · Covington, United States · Issued July 21, 2023

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 6 investigators are tied to this Form 483.

Inspectional observations

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

21 Jul 2023
21 CFR 106.55(a)

System of process controls to prevent adulteration

Cited by Elizabeth P Mayer, Jennifer M Heitz, Kimberly A Joseph, Said H Muse, Ashley R Karns, Kelsey L Vansickle

21 Jul 2023
21 CFR 106.6(a)

System of production; in-process controls

Cited by Elizabeth P Mayer, Jennifer M Heitz, Kimberly A Joseph, Said H Muse, Ashley R Karns, Kelsey L Vansickle

21 Jul 2023
21 CFR 117.35(d)

Sanitation of food-contact surfaces - Frequency

Cited by Elizabeth P Mayer, Jennifer M Heitz, Kimberly A Joseph, Said H Muse, Ashley R Karns, Kelsey L Vansickle

Inspected site

PNPBM Nutritionals, LLCCovington, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 106.55(a)Cited across public-safe Form 483 observations1x
21 CFR 106.6(a)Cited across public-safe Form 483 observations1x
21 CFR 117.35(d)Cited across public-safe Form 483 observations1x

Source document

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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