Atlas

Form 483

Parks Medical Electronics, Inc Form 483, 2010-06-21

FDA issued a Form 483 to Parks Medical Electronics, Inc on 2010-06-21 with 3 public-safe observations.

483· Form 483 issued3 observations

Parks Medical Electronics, Inc · Aloha, United States · Issued June 21, 2010

Overview

  • 3 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.

21 Jun 2010
21 CFR 820.20(c)

Management review - defined interval, sufficient frequency

Cited by Graham N Giesen

21 Jun 2010
21 CFR 820.22

Quality Audit/Reaudit - conducted

Cited by Graham N Giesen

21 Jun 2010
21 CFR 820.100(b)

Documentation

Cited by Graham N Giesen

Inspected site

PMParks Medical Electronics, IncAloha, United States

Inspection team

GNGraham N Giesen

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(b)Cited across public-safe Form 483 observations1x
21 CFR 820.20(c)Cited across public-safe Form 483 observations1x
21 CFR 820.22Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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