Atlas

Form 483

PuraCap Laboratories LLC Form 483, 2016-03-17

FDA issued a Form 483 to PuraCap Laboratories LLC on 2016-03-17 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

PuraCap Laboratories LLC · Franklin, United States · Issued March 17, 2016

Overview

  • 4 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.

17 Mar 2016
21 CFR 314.80(b)

Failure to develop written procedures

Cited by Nicholas L Paulin

17 Mar 2016
21 CFR 314.80(c)(1)(i)

Late submission of 15-day report

Cited by Nicholas L Paulin

17 Mar 2016
21 CFR 314.80(c)(2)

Late submission of annual safety reports

Cited by Nicholas L Paulin

17 Mar 2016
21 CFR 314.80(c)(2)

Late submission of annual safety repo

Cited by Nicholas L Paulin

Inspected site

PLPuraCap Laboratories LLCFranklin, United States

Inspection team

NLNicholas L Paulin

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 314.80(c)(2)Cited across public-safe Form 483 observations2x
21 CFR 314.80(b)Cited across public-safe Form 483 observations1x
21 CFR 314.80(c)(1)(i)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 4 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