Cooper Farms, Inc. — FDA Facility Profile

FEI 1520332

Cooper Farms, Inc. is an FDA-inspected facility (FEI 1520332) located in Fort Recovery, OH, US. RegDataLab tracks 16 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Sep 12, 2019: No Action Indicated (NAI)
Inspections on record
16 (4 VAI, 12 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Form 483 and inspection documents
1 in FDA's reading room

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Showing the 10 most recent of 16 inspections. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Sep 12, 2019No Action Indicated (NAI)No citations listed
Jun 28, 2018No Action Indicated (NAI)No citations listed
Jun 23, 2017No Action Indicated (NAI)No citations listed
Nov 18, 2015Voluntary Action Indicated (VAI)Daily reconciliation, Investigation/corrective action of actual vs theoretical (21 CFR 225.42(b)(7))
Three assays per year (21 CFR 225.58(b)(1))
First batch assay (21 CFR 225.58(b)(1))
Daily review of production records (21 CFR 225.102(b)(4))
Dec 9, 2014No Action Indicated (NAI)No citations listed
Oct 29, 2014No Action Indicated (NAI)No citations listed
Oct 17, 2014No Action Indicated (NAI)No citations listed
Feb 14, 2013No Action Indicated (NAI)No citations listed
Feb 6, 2013No Action Indicated (NAI)No citations listed
Jul 26, 2011Voluntary Action Indicated (VAI)No citations listed

Form 483s and inspection documents

Facility details

Company
Cooper Farms, Inc.
Location
Fort Recovery, OH (US)
Source
inspections

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.