Atlas

Form 483

Grifols Biomat USA Inc. Form 483, 2010-05-28

FDA issued a Form 483 to Grifols Biomat USA Inc. on 2010-05-28 with 2 public-safe observations.

483· Form 483 issued2 observations

Grifols Biomat USA Inc. · Richmond, United States · Issued May 28, 2010

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.

28 May 2010
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Paula J Bretz

28 May 2010
21 CFR 640.64(e)

Prevention of contamination

Cited by Paula J Bretz

Inspected site

GBGrifols Biomat USA Inc.Richmond, United States

Inspection team

PJPaula J Bretz

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 640.64(e)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