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Form 483

BioReliance Corporation Form 483, 2012-07-03

FDA issued a Form 483 to BioReliance Corporation on 2012-07-03 with 4 public-safe observations.

483· Form 483 issued4 observations

BioReliance Corporation · Rockville, United States · Issued July 3, 2012

Overview

  • 4 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.

3 Jul 2012
21 CFR 211.68(b)

input/output verification

Cited by Rachel C Harrington

3 Jul 2012
21 CFR 211.160(a)

Deviations from laboratory control requirements

Cited by Rachel C Harrington

3 Jul 2012
21 CFR 211.160(a)

Following/documenting laboratory controls

Cited by Rachel C Harrington

3 Jul 2012
21 CFR 211.194(a)(4)

Data secured in course of each test

Cited by Rachel C Harrington

Inspected site

BCBioReliance CorporationRockville, United States

Inspection team

RCRachel C Harrington

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(a)Cited across public-safe Form 483 observations2x
21 CFR 211.194(a)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 4 observations

The source PDF and 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