Atlas

Form 483

Tropichem Research Labs LLC Form 483, 2013-06-21

FDA issued a Form 483 to Tropichem Research Labs LLC on 2013-06-21 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Tropichem Research Labs LLC · Jupiter, United States · Issued June 21, 2013

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.

21 Jun 2013
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Tamara J Henderson

21 Jun 2013
21 CFR 211.166(a)

Lack of written stability program

Cited by Tamara J Henderson

Inspected site

TRTropichem Research Labs LLCJupiter, United States

Inspection team

TJTamara J Henderson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)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