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Form 483

Physician Engineered Products, Inc. Form 483, 2015-06-23

FDA issued a Form 483 to Physician Engineered Products, Inc. on 2015-06-23 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

Physician Engineered Products, Inc. · Fryeburg, United States · Issued June 23, 2015

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

23 Jun 2015
21 CFR 820.184

DHR - not or inadequately maintained

Cited by Stephen C Smith

23 Jun 2015
21 CFR 820.22

Quality Audit/Reaudit - conducted

Cited by Stephen C Smith

23 Jun 2015
21 CFR 820.25(b)

Training records

Cited by Stephen C Smith

23 Jun 2015
21 CFR 820.30(g)

Design validation - simulated testing

Cited by Stephen C Smith

Inspected site

PEPhysician Engineered Products, Inc.Fryeburg, United States

Inspection team

SCStephen C Smith

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.184Cited across public-safe Form 483 observations1x
21 CFR 820.22Cited across public-safe Form 483 observations1x
21 CFR 820.25(b)Cited across public-safe Form 483 observations1x
21 CFR 820.30(g)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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