Atlas

Form 483

MedPlast Medical, Inc. Form 483, 2010-12-15

FDA issued a Form 483 to MedPlast Medical, Inc. on 2010-12-15 with 2 public-safe observations.

483· Form 483 issued2 observations

MedPlast Medical, Inc. · Grand Rapids, United States · Issued December 15, 2010

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

15 Dec 2010
21 CFR 820.25(b)

Training records

Cited by Brian J Mundo, Anthony R Petriella

15 Dec 2010
21 CFR 820.70(a)

Production processes

Cited by Brian J Mundo, Anthony R Petriella

Inspected site

MMMedPlast Medical, Inc.Grand Rapids, United States

Inspection team

BJBrian J Mundo
ARAnthony R Petriella

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.25(b)Cited across public-safe Form 483 observations1x
21 CFR 820.70(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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