Form 483

Pearson Dental Supplies Inc Form 483, 2016-08-15

FDA issued a Form 483 to Pearson Dental Supplies Inc on 2016-08-15 with 12 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health12 observations

Pearson Dental Supplies Inc · Sylmar, United States · Issued August 15, 2016

Overview

  • 12 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.

15 Aug 2016
21 CFR 1271.180(b)

Review and approval-responsible person

Cited by Donna L Besone

15 Aug 2016
21 CFR 1271.180(b)

Review and approval-responsible person

Cited by Donna L Besone

15 Aug 2016
21 CFR 1271.180(b)

Review and approval-responsible person

Cited by Donna L Besone

15 Aug 2016
21 CFR 1271.180(b)

Review and approval-responsible person

Cited by Donna L Besone

15 Aug 2016
21 CFR 1271.265(f)

Return to inventory--procedures

Cited by Donna L Besone

Inspected site

PDPearson Dental Supplies IncSylmar, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.180(b)Cited across public-safe Form 483 observations4x
21 CFR 1271.265(f)Cited across public-safe Form 483 observations4x
21 CFR 820.198(a)Cited across public-safe Form 483 observations4x

Full 483 report

Get the verbatim text of all 12 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