Form 483

Nick Sciabica & Sons, A Corporation Form 483, 2011-05-31

FDA issued a Form 483 to Nick Sciabica & Sons, A Corporation on 2011-05-31 with 4 public-safe observations.

483· Form 483 issued4 observations

Nick Sciabica & Sons, A Corporation · Modesto, United States · Issued May 31, 2011

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

31 May 2011
21 CFR 110.10(b)(4)

Unsecured jewelry

Cited by Edna J Hidalgo, Karen D Phung

31 May 2011
21 CFR 110.10(b)(6)

Failure to wear

Cited by Edna J Hidalgo, Karen D Phung

31 May 2011
21 CFR 110.37(e)

Running water at suitable temperature

Cited by Edna J Hidalgo, Karen D Phung

31 May 2011
21 CFR 110.40(a)

Precluding contaminants

Cited by Edna J Hidalgo, Karen D Phung

Inspected site

NSNick Sciabica & Sons, A CorporationModesto, United States

Inspection team

KDKaren D Phung

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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