Form 483

Perry Dynamics Inc Form 483, 2016-08-19

FDA issued a Form 483 to Perry Dynamics Inc on 2016-08-19 with 8 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health8 observations

Perry Dynamics Inc · Decatur, United States · Issued August 19, 2016

Overview

  • 8 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.

19 Aug 2016
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Brian D Nicholson

19 Aug 2016
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Brian D Nicholson

19 Aug 2016
21 CFR 820.181

DMR - not or inadequately maintained

Cited by Brian D Nicholson

19 Aug 2016
21 CFR 820.181

DMR - not or inadequately maintained

Cited by Brian D Nicholson

19 Aug 2016
21 CFR 820.184

DHR - not or inadequately maintained

Cited by Brian D Nicholson

Inspected site

PDPerry Dynamics IncDecatur, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations2x
21 CFR 820.181Cited across public-safe Form 483 observations2x
21 CFR 820.184Cited across public-safe Form 483 observations2x
21 CFR 820.30(j)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 8 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