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Form 483

ImmuCell Corporation Form 483, 2018-09-17

FDA issued a Form 483 to ImmuCell Corporation on 2018-09-17 with 1 public-safe observation.

483· Form 483 issuedAnimal Drugs & Feeds1 observation

ImmuCell Corporation · Portland, United States · Issued September 17, 2018

Overview

  • 1 public-safe observation is 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.

17 Sep 2018
21 CFR 211.25(a)

Training , Education , Experience overall

Cited by John P Mistler

Inspected site

ICImmuCell CorporationPortland, United States

Inspection team

JPJohn P Mistler

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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