Atlas

Form 483

Eclectic Institute Inc Form 483, 2011-12-19

FDA issued a Form 483 to Eclectic Institute Inc on 2011-12-19 with 2 public-safe observations.

483· Form 483 issued2 observations

Eclectic Institute Inc · Gresham, United States · Issued December 19, 2011

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

19 Dec 2011
21 CFR 110.35(a)

Buildings/sanitary

Cited by Ian J Thomson, Crystal A Harlan

19 Dec 2011
21 CFR 110.80

Reject and rework

Cited by Ian J Thomson, Crystal A Harlan

Inspected site

EIEclectic Institute IncGresham, United States

Inspection team

IJIan J Thomson
CACrystal A Harlan

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.80Cited 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