Form 483

Ward Photonics, LLC Form 483, 2023-01-19

FDA issued a Form 483 to Ward Photonics, LLC on 2023-01-19 with 10 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health10 observations

Ward Photonics, LLC · Cocoa Beach, United States · Issued January 19, 2023

Overview

  • 10 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.

19 Jan 2023
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Stanley B Eugene

19 Jan 2023
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Stanley B Eugene

19 Jan 2023
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Stanley B Eugene

19 Jan 2023
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Stanley B Eugene

19 Jan 2023
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Stanley B Eugene

Inspected site

WPWard Photonics, LLCCocoa Beach, 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 820.100(a)Cited across public-safe Form 483 observations2x
21 CFR 820.198(a)Cited across public-safe Form 483 observations2x
21 CFR 820.50Cited across public-safe Form 483 observations2x
21 CFR 820.50(b)Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 10 observations

The source PDF, 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