Atlas

Form 483

Professional Disposables International, Inc. Form 483, 2017-12-01

FDA issued a Form 483 to Professional Disposables International, Inc. on 2017-12-01 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Professional Disposables International, Inc. · Orangeburg, United States · Issued December 1, 2017

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.

1 Dec 2017
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Helen B Ricalde

1 Dec 2017
21 CFR 314.81(b)(1)(ii)

Failure to meet specifications

Cited by Helen B Ricalde

Inspected site

PDProfessional Disposables International, Inc.Orangeburg, United States

Inspection team

HBHelen B Ricalde

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 314.81(b)(1)(ii)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