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Form 483

Centrum Valley Farms, LLP Form 483, 2013-07-11

FDA issued a Form 483 to Centrum Valley Farms, LLP on 2013-07-11 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Centrum Valley Farms, LLP · Clarion, United States · Issued July 11, 2013

Overview

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

Inspectional observations

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

11 Jul 2013
21 CFR 118.4(b)(3)

Cross contamination from people

Cited by Monica M Mcclure, Robert J Ham, Karen M Montgomery, Edward E Lockwood, Eric T Huebler, Dawn C Olenjack, Steven P Allen, Brett R Havranek, Steven D Kehoe, Shaun M Olson, Brittany D Terhar, Eric M Mueller, Nicole J Conklin, Kathleen J Close, Erin C Dugan, James J Houlihan, Shawn B Johnson, Samuel K Gibbons, Andrew A Hoopes, Candace S Tucker

11 Jul 2013
21 CFR 118.10(b)(2)

Date and time of activity

Cited by Monica M Mcclure, Robert J Ham, Karen M Montgomery, Edward E Lockwood, Eric T Huebler, Dawn C Olenjack, Steven P Allen, Brett R Havranek, Steven D Kehoe, Shaun M Olson, Brittany D Terhar, Eric M Mueller, Nicole J Conklin, Kathleen J Close, Erin C Dugan, James J Houlihan, Shawn B Johnson, Samuel K Gibbons, Andrew A Hoopes, Candace S Tucker

11 Jul 2013
21 CFR 118.10(b)(3)

Signatures or initials on operational records

Cited by Monica M Mcclure, Robert J Ham, Karen M Montgomery, Edward E Lockwood, Eric T Huebler, Dawn C Olenjack, Steven P Allen, Brett R Havranek, Steven D Kehoe, Shaun M Olson, Brittany D Terhar, Eric M Mueller, Nicole J Conklin, Kathleen J Close, Erin C Dugan, James J Houlihan, Shawn B Johnson, Samuel K Gibbons, Andrew A Hoopes, Candace S Tucker

Inspected site

CVCentrum Valley Farms, LLPClarion, United States

Inspection team

MMMonica M Mcclure
RJRobert J Ham
KMKaren M Montgomery
EEEdward E Lockwood
ETEric T Huebler
DCDawn C Olenjack
SPSteven P Allen
BRBrett R Havranek
SDSteven D Kehoe
SMShaun M Olson
BDBrittany D Terhar
EMEric M Mueller
NJNicole J Conklin
KJKathleen J Close
ECErin C Dugan
JJJames J Houlihan
SBShawn B Johnson
SKSamuel K Gibbons
AAAndrew A Hoopes
CSCandace S Tucker

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 118.4(b)(3)Cited 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