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Form 483

NIH Donor Center at Fishers Lane Form 483, 2019-07-11

FDA issued a Form 483 to NIH Donor Center at Fishers Lane on 2019-07-11 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

NIH Donor Center at Fishers Lane · Rockville, United States · Issued July 11, 2019

Overview

  • 3 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.

11 Jul 2019
21 CFR 630.10(g)(1)

Proof Of Identity

Cited by Shavon L Square

11 Jul 2019
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Shavon L Square

11 Jul 2019
21 CFR 640.21(g)

Informed consent

Cited by Shavon L Square

Inspected site

NDNIH Donor Center at Fishers LaneRockville, United States

Inspection team

SLShavon L Square

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 630.10(g)(1)Cited across public-safe Form 483 observations1x
21 CFR 640.21(g)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 3 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