Atlas

Form 483

Peak Nutritional Products, LLC Form 483, 2022-04-27

FDA issued a Form 483 to Peak Nutritional Products, LLC on 2022-04-27 with 10 public-safe observations.

483· Form 483 issuedFoods & Cosmetics10 observations

Peak Nutritional Products, LLC · Tampa, United States · Issued April 27, 2022

Overview

  • 10 public-safe observations are available for this inspection.
  • 10 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.

27 Apr 2022
21 CFR 111.105(b)

Quality control - supplier qualification

Cited by Matthew B Thomaston, Lourdes Andujar, Sharon Giamberini, Haijing Hu, Carol S Davis, Anthony W Lee

27 Apr 2022
21 CFR 111.153

Written procedures - components

Cited by Matthew B Thomaston, Lourdes Andujar, Sharon Giamberini, Haijing Hu, Carol S Davis, Anthony W Lee

27 Apr 2022
21 CFR 111.255(b)

Batch record - complete

Cited by Matthew B Thomaston, Lourdes Andujar, Sharon Giamberini, Haijing Hu, Carol S Davis, Anthony W Lee

27 Apr 2022
21 CFR 111.353

Manufacturing operations - written procedures

Cited by Matthew B Thomaston, Lourdes Andujar, Sharon Giamberini, Haijing Hu, Carol S Davis, Anthony W Lee

27 Apr 2022
21 CFR 111.360

Manufacturing operations - sanitation

Cited by Matthew B Thomaston, Lourdes Andujar, Sharon Giamberini, Haijing Hu, Carol S Davis, Anthony W Lee

Inspected site

PNPeak Nutritional Products, LLCTampa, United States

Inspection team

MBMatthew B Thomaston
LALourdes Andujar
SGSharon Giamberini
HHHaijing Hu
CSCarol S Davis
AWAnthony W Lee

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.105(b)Cited across public-safe Form 483 observations1x
21 CFR 111.153Cited across public-safe Form 483 observations1x
21 CFR 111.255(b)Cited across public-safe Form 483 observations1x
21 CFR 111.353Cited across public-safe Form 483 observations1x
21 CFR 111.360Cited across public-safe Form 483 observations1x
21 CFR 111.455(c)Cited across public-safe Form 483 observations1x
21 CFR 111.560(c)Cited across public-safe Form 483 observations1x
21 CFR 111.70(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.70(e)Cited across public-safe Form 483 observations1x
21 CFR 111.75(h)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 10 observations

The full inspection record, as Atlas holds it, 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