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Form 483

MedPlast Medical, Inc. Form 483, 2014-09-11

FDA issued a Form 483 to MedPlast Medical, Inc. on 2014-09-11 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

MedPlast Medical, Inc. · Grand Rapids, United States · Issued September 11, 2014

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

11 Sep 2014
21 CFR 820.72(b)

Remedial action

Cited by Thomas A Peter

Inspected site

MMMedPlast Medical, Inc.Grand Rapids, United States

Inspection team

TAThomas A Peter

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.72(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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