Form 483

Olivera Egg Ranch LLC Form 483, 2014-10-17

FDA issued a Form 483 to Olivera Egg Ranch LLC on 2014-10-17 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Olivera Egg Ranch LLC · French Camp, United States · Issued October 17, 2014

Overview

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

Inspectional observations

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

17 Oct 2014
21 CFR 118.4

Written SE plan lacks required elements

Cited by Marissa J Chan, Andrew E Kay, Damon A Growl

17 Oct 2014
21 CFR 118.8(a)

Method to be used, environmental samples

Cited by Marissa J Chan, Andrew E Kay, Damon A Growl

17 Oct 2014
21 CFR 118.10(b)(2)

Date and time of activity

Cited by Marissa J Chan, Andrew E Kay, Damon A Growl

17 Oct 2014
21 CFR 118.10(b)(3)

Signatures or initials on operational records

Cited by Marissa J Chan, Andrew E Kay, Damon A Growl

Inspected site

OEOlivera Egg Ranch LLCFrench Camp, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 118.10(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 118.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 118.4Cited across public-safe Form 483 observations1x
21 CFR 118.8(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