Atlas

Form 483

Premier Dental Products Company Form 483, 2014-02-21

FDA issued a Form 483 to Premier Dental Products Company on 2014-02-21 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Premier Dental Products Company · Philadelphia, United States · Issued February 21, 2014

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

21 Feb 2014
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Raffi B Papazian

21 Feb 2014
21 CFR 820.75(c)

Documentation - review in response to changes or deviations

Cited by Raffi B Papazian

21 Feb 2014
21 CFR 820.100(b)

Documentation

Cited by Raffi B Papazian

Inspected site

PDPremier Dental Products CompanyPhiladelphia, United States

Inspection team

RBRaffi B Papazian

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(b)Cited across public-safe Form 483 observations1x
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x
21 CFR 820.75(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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