Atlas

Form 483

NIH Donor Center at Fishers Lane Form 483, 2017-04-17

FDA issued a Form 483 to NIH Donor Center at Fishers Lane on 2017-04-17 with 4 public-safe observations.

483· Form 483 issuedBiologics4 observations

NIH Donor Center at Fishers Lane · Rockville, United States · Issued April 17, 2017

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

17 Apr 2017
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by La-Tasha M Gunter

17 Apr 2017
21 CFR 606.100(b)(15)

Schedules and procedures for equipment & calibration

Cited by La-Tasha M Gunter

17 Apr 2017
21 CFR 606.40(d)(1)

Provide adequate disposal of trash & discarded items

Cited by La-Tasha M Gunter

17 Apr 2017
21 CFR 630.10(f)(6)(ii)

Physical Assessment Determination - Skin Examination

Cited by La-Tasha M Gunter

Inspected site

NDNIH Donor Center at Fishers LaneRockville, United States

Inspection team

LMLa-Tasha M Gunter

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(b)(15)Cited across public-safe Form 483 observations1x
21 CFR 606.40(d)(1)Cited across public-safe Form 483 observations1x
21 CFR 630.10(f)(6)(ii)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 observations

The full inspection record, as Atlas holds it, 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