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PRENTKE ROMICH CO. FDA Inspection Record

FEI 3010819851 · Inspections, Form 483s, warning letters and import refusals

PRENTKE ROMICH CO. is an FDA-registered facility (FEI 3010819851) located in WOOSTER, OH, US. RegDataLab tracks 5 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
May 1, 2025: No Action Indicated (NAI)
Inspections on record
5 (4 VAI, 1 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

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

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
May 1, 2025No Action Indicated (NAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Lack of or inadequate DHR procedures (21 CFR 820.184)
Documentation (21 CFR 820.100(b))
Records not kept (21 CFR 806.20(a))
and 1 more
Dec 4, 2018Voluntary Action Indicated (VAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Design validation - Risk analysis (21 CFR 820.30(g))
Design changes - Lack of or Inadequate Procedures (21 CFR 820.30(i))
Lack of or inadequate procedures (21 CFR 820.100(a))
Nov 30, 2018Voluntary Action Indicated (VAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Lack of or inadequate procedures (21 CFR 820.100(a))
Design Validation - Risk analysis not performed/inadequate (21 CFR 820.30(g))
Feb 15, 2013Voluntary Action Indicated (VAI)Design review - Lack of or inadequate procedures (21 CFR 820.30(e))
Lack of or inadequate final acceptance procedures (21 CFR 820.80(d))
Lack of or inadequate procedures (21 CFR 820.100(a))
Jul 9, 2009Voluntary Action Indicated (VAI)No citations listed

Facility details

Company
Prentke Romich Company
Location
WOOSTER, OH (US)
Source
device

FDA data resources

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