Form 483

Pillar5 Pharma Inc Form 483, 2020-02-21

FDA issued a Form 483 to Pillar5 Pharma Inc on 2020-02-21 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Pillar5 Pharma Inc · Arnprior, Canada · Issued February 21, 2020

Overview

  • 2 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

21 Feb 2020
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Sarah E Rhoades

21 Feb 2020
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Sarah E Rhoades

Inspected site

PPPillar5 Pharma IncArnprior, Canada

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations2x

Source document

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Form 483 source document

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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