Atlas

Form 483

John Nagle Co. Form 483, 2011-08-19

FDA issued a Form 483 to John Nagle Co. on 2011-08-19 with 2 public-safe observations.

483· Form 483 issued2 observations

John Nagle Co. · Boston, United States · Issued August 19, 2011

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.

19 Aug 2011
21 CFR 123.6(c)(3)

Critical limits

Cited by Pamela L Ogonowski

19 Aug 2011
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Pamela L Ogonowski

Inspected site

JNJohn Nagle Co.Boston, United States

Inspection team

PLPamela L Ogonowski

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(c)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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