Atlas

Form 483

Sanitor Corporation Form 483, 2016-04-28

FDA issued a Form 483 to Sanitor Corporation on 2016-04-28 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Sanitor Corporation · Stanton, United States · Issued April 28, 2016

Overview

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

Inspectional observations

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

28 Apr 2016
21 CFR 211.184(c)

Individual inventory record

Cited by Lance A Finnical, Richmond K Yip

28 Apr 2016
21 CFR 211.84(a)

Components withheld from use pending release

Cited by Lance A Finnical, Richmond K Yip

Inspected site

SCSanitor CorporationStanton, United States

Inspection team

LALance A Finnical
RKRichmond K Yip

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.184(c)Cited across public-safe Form 483 observations1x
21 CFR 211.84(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

Every observation in full, 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