Atlas

Form 483

Leading Pharma, LLC Form 483, 2017-04-14

FDA issued a Form 483 to Leading Pharma, LLC on 2017-04-14 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Leading Pharma, LLC · Fairfield, United States · Issued April 14, 2017

Overview

  • 4 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.

14 Apr 2017
21 CFR 314.80(c)(2)

Failure to report non-alert ADEs

Cited by Zakaria I Ganiyu

14 Apr 2017
21 CFR 314.80(c)(2)

Failure to report non-alert ADEs

Cited by Zakaria I Ganiyu

14 Apr 2017
21 CFR 314.81(b)(1)(ii)

Failure to meet specifications

Cited by Zakaria I Ganiyu

14 Apr 2017
21 CFR 314.81(b)(1)(ii)

Failure to meet specifications

Cited by Zakaria I Ganiyu

Inspected site

LPLeading Pharma, LLCFairfield, United States

Inspection team

ZIZakaria I Ganiyu

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 314.81(b)(1)(ii)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 4 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