Form 483

Midway Co-op Association Form 483, 2019-05-03

FDA issued a Form 483 to Midway Co-op Association on 2019-05-03 with 8 public-safe observations.

483· Form 483 issuedAnimal Drugs & Feeds8 observations

Midway Co-op Association · Osborne, United States · Issued May 3, 2019

Overview

  • 8 public-safe observations are available for this inspection.
  • 4 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.

3 May 2019
21 CFR 225.42(b)

Adequate procedures established

Cited by Kristi B Panzer

3 May 2019
21 CFR 225.58(b)(1)

Three assays per year

Cited by Kristi B Panzer

3 May 2019
21 CFR 225.65(b)

Reasonable and effective procedures followed

Cited by Kristi B Panzer

3 May 2019
21 CFR 507.34(a)(1)

Preventive Controls

Cited by Kristi B Panzer

3 May 2019
21 CFR 225.42(b)

Adequate procedures established

Cited by Kristi B Panzer

Inspected site

MCMidway Co-op AssociationOsborne, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 225.42(b)Cited across public-safe Form 483 observations2x
21 CFR 225.58(b)(1)Cited across public-safe Form 483 observations2x
21 CFR 225.65(b)Cited across public-safe Form 483 observations2x
21 CFR 507.34(a)(1)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 8 observations

The full inspection record, as Atlas holds it, 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