Atlas

Form 483

Precision X-ray, Inc. Form 483, 2015-01-26

FDA issued a Form 483 to Precision X-ray, Inc. on 2015-01-26 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Precision X-ray, Inc. · North Branford, United States · Issued January 26, 2015

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

26 Jan 2015
21 CFR 1002.13

Failure to submit

Cited by Jeffrey J Thibodeau

26 Jan 2015
21 CFR 1020.40(c)(5)

Ground fault

Cited by Jeffrey J Thibodeau

Inspected site

PXPrecision X-ray, Inc.North Branford, United States

Inspection team

JJJeffrey J Thibodeau

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1002.13Cited across public-safe Form 483 observations1x
21 CFR 1020.40(c)(5)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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