Atlas

Form 483

NeuroScience Solutions, Inc. Form 483, 2023-04-25

FDA issued a Form 483 to NeuroScience Solutions, Inc. on 2023-04-25 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

NeuroScience Solutions, Inc. · Osceola, United States · Issued April 25, 2023

Overview

  • 3 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.

25 Apr 2023
21 CFR 111.260(k)

Batch record - packaging, labeling

Cited by Krista K Petersen

25 Apr 2023
21 CFR 111.303

Written procedures - tests, examinations; specifications met

Cited by Krista K Petersen

25 Apr 2023
21 CFR 111.535(b)(2)

Records - ret'nd dietary supplement: material review, dispos

Cited by Krista K Petersen

Inspected site

NSNeuroScience Solutions, Inc.Osceola, United States

Inspection team

KKKrista K Petersen

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.260(k)Cited across public-safe Form 483 observations1x
21 CFR 111.303Cited across public-safe Form 483 observations1x
21 CFR 111.535(b)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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