Form 483

Keystone Cooperative Inc. Form 483, 2016-06-24

FDA issued a Form 483 to Keystone Cooperative Inc. on 2016-06-24 with 6 public-safe observations.

483· Form 483 issuedAnimal Drugs & Feeds6 observations

Keystone Cooperative Inc. · Holland, United States · Issued June 24, 2016

Overview

  • 6 public-safe observations are available for this inspection.
  • 3 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.

24 Jun 2016
21 CFR 225.20(a)

Facilities features

Cited by Theodore N Sietsema

24 Jun 2016
21 CFR 225.42(b)

Adequate procedures established

Cited by Theodore N Sietsema

24 Jun 2016
21 CFR 225.42(b)(6)

Lot number or shipment I.D. number

Cited by Theodore N Sietsema

24 Jun 2016
21 CFR 225.20(a)

Facilities features

Cited by Theodore N Sietsema

24 Jun 2016
21 CFR 225.42(b)

Adequate procedures established

Cited by Theodore N Sietsema

Inspected site

KCKeystone Cooperative Inc.Holland, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 225.20(a)Cited across public-safe Form 483 observations2x
21 CFR 225.42(b)Cited across public-safe Form 483 observations2x
21 CFR 225.42(b)(6)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 6 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