Atlas

Form 483

Bimeda, Inc. Form 483, 2017-11-17

FDA issued a Form 483 to Bimeda, Inc. on 2017-11-17 with 2 public-safe observations.

483· Form 483 issuedAnimal Drugs & Feeds2 observations

Bimeda, Inc. · Le Sueur, United States · Issued November 17, 2017

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.

17 Nov 2017
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Tenzin Jangchup, James K Ireland

17 Nov 2017
21 CFR 211.80(b)

Handling and Storage to Prevent Contamination

Cited by Tenzin Jangchup, James K Ireland

Inspected site

BIBimeda, Inc.Le Sueur, United States

Inspection team

TJTenzin Jangchup
JKJames K Ireland

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.80(b)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