Form 483

Danville Regional Medical Center/Blood Bank Form 483, 2014-03-03

FDA issued a Form 483 to Danville Regional Medical Center/Blood Bank on 2014-03-03 with 9 public-safe observations.

483· Form 483 issuedBiologics9 observations

Danville Regional Medical Center/Blood Bank · Danville, United States · Issued March 3, 2014

Overview

  • 9 public-safe observations are available for this inspection.
  • 7 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 Mar 2014
21 CFR 211.68(b)

input/output verification

Cited by Carrie L Doupnik

3 Mar 2014
21 CFR 606.60(b)

Equipment calibration frequency

Cited by Carrie L Doupnik

3 Mar 2014
21 CFR 606.100(c)

Record review prior to release

Cited by Carrie L Doupnik

3 Mar 2014
21 CFR 606.100(c)

Thorough investigations

Cited by Carrie L Doupnik

3 Mar 2014
21 CFR 606.160(a)(1)

Concurrent documentation

Cited by Carrie L Doupnik

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(c)Cited across public-safe Form 483 observations2x
21 CFR 606.160(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x
21 CFR 606.160(b)Cited across public-safe Form 483 observations1x
21 CFR 606.170(a)Cited across public-safe Form 483 observations1x
21 CFR 606.60(b)Cited across public-safe Form 483 observations1x
21 CFR 640.3(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 9 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