Atlas

Form 483

Tris Pharma Inc. Form 483, 2018-04-16

FDA issued a Form 483 to Tris Pharma Inc. on 2018-04-16 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Tris Pharma Inc. · Monmouth Junction, United States · Issued April 16, 2018

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.

16 Apr 2018
21 CFR 314.80(b)

Failure to develop written procedures

Cited by Marcelo O Mangalindan

16 Apr 2018
21 CFR 314.80(c)(1)(i)

Late submission of 15-day report

Cited by Marcelo O Mangalindan

Inspected site

TPTris Pharma Inc.Monmouth Junction, United States

Inspection team

MOMarcelo O Mangalindan

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
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

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