Atlas

Form 483

Premium Plus Dental Supplies Inc. Form 483, 2014-01-08

FDA issued a Form 483 to Premium Plus Dental Supplies Inc. on 2014-01-08 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Premium Plus Dental Supplies Inc. · Brooklyn, United States · Issued January 8, 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.

8 Jan 2014
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Ronald Ifraimov

8 Jan 2014
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Ronald Ifraimov

8 Jan 2014
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Ronald Ifraimov

Inspected site

PPPremium Plus Dental Supplies Inc.Brooklyn, United States

Inspection team

RIRonald Ifraimov

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations1x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)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