Form 483

Ward Photonics, LLC Form 483, 2019-04-18

FDA issued a Form 483 to Ward Photonics, LLC on 2019-04-18 with 16 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health16 observations

Ward Photonics, LLC · Cocoa Beach, United States · Issued April 18, 2019

Overview

  • 16 public-safe observations are available for this inspection.
  • 5 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.

18 Apr 2019
21 CFR 803.50(a)(1)

Report of Death or Serious Injury

Cited by Richard K Vogel

18 Apr 2019
21 CFR 803.50(a)(1)

Report of Death or Serious Injury

Cited by Richard K Vogel

18 Apr 2019
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Richard K Vogel

18 Apr 2019
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Richard K Vogel

18 Apr 2019
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by Richard K Vogel

Inspected site

WPWard Photonics, LLCCocoa Beach, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.198(a)Cited across public-safe Form 483 observations4x
21 CFR 820.22Cited across public-safe Form 483 observations4x
21 CFR 820.70(c)Cited across public-safe Form 483 observations4x
21 CFR 803.50(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 820.50Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 16 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