Atlas

Form 483

American National Red Cross, Penn Jersey Region Form 483, 2012-08-01

FDA issued a Form 483 to American National Red Cross, Penn Jersey Region on 2012-08-01 with 3 public-safe observations.

483· Form 483 issued3 observations

American National Red Cross, Penn Jersey Region · Philadelphia, United States · Issued August 1, 2012

Overview

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

Inspectional observations

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

1 Aug 2012
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Nikisha M Bolden, Gayle S Lawson, Megan M Lauff, Linda M Hoover

1 Aug 2012
21 CFR 606.100(c)

Thorough investigations

Cited by Nikisha M Bolden, Gayle S Lawson, Megan M Lauff, Linda M Hoover

1 Aug 2012
21 CFR 606.160(a)(1)

Person performing, test results, interpretation

Cited by Nikisha M Bolden, Gayle S Lawson, Megan M Lauff, Linda M Hoover

Inspected site

ANAmerican National Red Cross, Penn Jersey RegionPhiladelphia, United States

Inspection team

NMNikisha M Bolden
GSGayle S Lawson
MMMegan M Lauff
LMLinda M Hoover

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)Cited across public-safe Form 483 observations1x
21 CFR 606.100(c)Cited across public-safe Form 483 observations1x
21 CFR 606.160(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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