Form 483

Sanitor Corporation Form 483, 2024-05-10

FDA issued a Form 483 to Sanitor Corporation on 2024-05-10 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Sanitor Corporation · Stanton, United States · Issued May 10, 2024

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

10 May 2024
21 CFR 211.166(a)

Results not used for expiration dates, storage cond.

Cited by Darren S Brown

10 May 2024
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Darren S Brown

Inspected site

SCSanitor CorporationStanton, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 2 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