Atlas

Form 483

Quest Diagnostics Nichols Institute Form 483, 2021-08-30

FDA issued a Form 483 to Quest Diagnostics Nichols Institute on 2021-08-30 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

Quest Diagnostics Nichols Institute · Chantilly, United States · Issued August 30, 2021

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.

30 Aug 2021
21 CFR 1271.270(d)

Retention time (10 year rules)

Cited by La-Tasha M Gunter

30 Aug 2021
21 CFR 1271.80(c)

Manufacturer instructions not followed

Cited by La-Tasha M Gunter

Inspected site

QDQuest Diagnostics Nichols InstituteChantilly, United States

Inspection team

LMLa-Tasha M Gunter

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.270(d)Cited across public-safe Form 483 observations1x
21 CFR 1271.80(c)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.

Book a demoStart a free trial

Full 483 report

Get the verbatim text of all 2 observations

The source PDF, 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