Atlas

Form 483

William Kleinberger & Sons, Inc. Form 483, 2011-03-17

FDA issued a Form 483 to William Kleinberger & Sons, Inc. on 2011-03-17 with 3 public-safe observations.

483· Form 483 issued3 observations

William Kleinberger & Sons, Inc. · Scranton, United States · Issued March 17, 2011

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.

17 Mar 2011
21 CFR 114.80(a)

Quality control procedures

Cited by Bradley E Benasutti

17 Mar 2011
21 CFR 114.80(a)(2)

pH testing

Cited by Bradley E Benasutti

17 Mar 2011
21 CFR 114.83

Scheduled process establishment

Cited by Bradley E Benasutti

Inspected site

WKWilliam Kleinberger & Sons, Inc.Scranton, United States

Inspection team

BEBradley E Benasutti

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 114.80(a)Cited across public-safe Form 483 observations1x
21 CFR 114.80(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 114.83Cited 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