Atlas

Form 483

Vision Technical Molding Form 483, 2014-08-27

FDA issued a Form 483 to Vision Technical Molding on 2014-08-27 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Vision Technical Molding · Manchester, United States · Issued August 27, 2014

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

27 Aug 2014
21 CFR 820.70(c)

Environmental control Lack of or inadequate procedures

Cited by Nealie C Newberger, Jeffrey J Thibodeau, Nealie Newberger

27 Aug 2014
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Nealie C Newberger, Jeffrey J Thibodeau, Nealie Newberger

Inspected site

VTVision Technical MoldingManchester, United States

Inspection team

NCNealie C Newberger
JJJeffrey J Thibodeau
NNNealie Newberger

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.70(c)Cited across public-safe Form 483 observations1x
21 CFR 820.75(a)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