Form 483

Merit Pet Products, LLC Form 483, 2017-10-06

FDA issued a Form 483 to Merit Pet Products, LLC on 2017-10-06 with 6 public-safe observations.

483· Form 483 issuedAnimal Drugs & Feeds6 observations

Merit Pet Products, LLC · Cumberland, United States · Issued October 6, 2017

Overview

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

6 Oct 2017
21 CFR 211.137(d)

Expiration date location on labeling

Cited by Christopher Janik

6 Oct 2017
21 CFR 211.150(b)

Recall facilitation

Cited by Christopher Janik

6 Oct 2017
21 CFR 211.186(a)

Master production and control records, procedure

Cited by Christopher Janik

6 Oct 2017
21 CFR 211.198(b)

Complaint File Location

Cited by Christopher Janik

6 Oct 2017
21 CFR 211.22(a)

Lack of quality control unit

Cited by Christopher Janik

Inspected site

MPMerit Pet Products, LLCCumberland, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.137(d)Cited across public-safe Form 483 observations1x
21 CFR 211.150(b)Cited across public-safe Form 483 observations1x
21 CFR 211.186(a)Cited across public-safe Form 483 observations1x
21 CFR 211.198(b)Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.56(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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