Atlas

Form 483

Supplement Manufacturing Partner, Inc. Form 483, 2022-08-12

FDA issued a Form 483 to Supplement Manufacturing Partner, Inc. on 2022-08-12 with 9 public-safe observations.

483· Form 483 issuedFoods & Cosmetics9 observations

Supplement Manufacturing Partner, Inc. · Edgewood, United States · Issued August 12, 2022

Overview

  • 9 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.

12 Aug 2022
21 CFR 111.455(a)

Hold - temperature, humidity, light

Cited by Meredith P Soehl

12 Aug 2022
21 CFR 111.455(a)

Hold - temperature, humidity, light

Cited by Meredith P Soehl

12 Aug 2022
21 CFR 111.455(c)

Hold - mix-up, contamination, deterioration

Cited by Meredith P Soehl

12 Aug 2022
21 CFR 111.455(c)

Hold - mix-up, contamination, deterioration

Cited by Meredith P Soehl

12 Aug 2022
21 CFR 111.503

Written procedures - returned dietary supplement

Cited by Meredith P Soehl

Inspected site

SMSupplement Manufacturing Partner, Inc.Edgewood, United States

Inspection team

MPMeredith P Soehl

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.455(a)Cited across public-safe Form 483 observations3x
21 CFR 111.455(c)Cited across public-safe Form 483 observations3x
21 CFR 111.503Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 9 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