Form 483

My Bar-K, LLC Form 483, 2013-03-04

FDA issued a Form 483 to My Bar-K, LLC on 2013-03-04 with 5 public-safe observations.

483· Form 483 issuedAnimal Drugs & Feeds5 observations

My Bar-K, LLC · Munnsville, United States · Issued March 4, 2013

Overview

  • 5 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.

4 Mar 2013
21 CFR 530.11(a)

Dosage level

Cited by Bruce G Cooper

4 Mar 2013
FDCA 402(a)(4)

Feeding colostrum

Cited by Bruce G Cooper

4 Mar 2013
FDCA 402(a)(4)

Record keeping

Cited by Bruce G Cooper

4 Mar 2013
FDCA 402(a)(4)

System for administration of drugs

Cited by Bruce G Cooper

4 Mar 2013
FDCA 501(a)(5)

Conditions of use

Cited by Bruce G Cooper

Inspected site

MBMy Bar-K, LLCMunnsville, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
FDCA 402(a)(4)Cited across public-safe Form 483 observations3x
21 CFR 530.11(a)Cited across public-safe Form 483 observations1x
FDCA 501(a)(5)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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