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HAMMILL MFG. CO. FDA Inspection Record

FEI 3000215103 · Inspections, Form 483s, warning letters and import refusals

HAMMILL MFG. CO. is an FDA-registered facility (FEI 3000215103) located in MAUMEE, OH, US. RegDataLab tracks 6 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Mar 13, 2025: No Action Indicated (NAI)
Inspections on record
6 (2 VAI, 4 NAI)
Last OAI inspection
None on record
Warning letters
1 listed by FDA for this FEI, latest Jan 6, 2009

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
Mar 13, 2025No Action Indicated (NAI)No citations listed
Nov 17, 2017Voluntary Action Indicated (VAI)Lack/Inad procedure-Monitoring/Control of Validated Proces (21 CFR 820.75(b))
Lack of or inadequate process validation (21 CFR 820.75(a))
Jan 30, 2015Voluntary Action Indicated (VAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Management review - Lack of or inadequate procedures (21 CFR 820.20(c))
Lack of Written MDR Procedures (21 CFR 803.17)
Sep 24, 2012No Action Indicated (NAI)No citations listed
Sep 2, 2009No Action Indicated (NAI)DMR device specifications (21 CFR 820.181(a))
DMR production process specifications (21 CFR 820.181(b))
Investigation of device failures (21 CFR 820.198(c))
Not approved or obsolete document retrieval (21 CFR 820.40(a))
and 4 more
Nov 10, 2008No Action Indicated (NAI)DMR device specifications (21 CFR 820.181(a))
DMR production process specifications (21 CFR 820.181(b))
Investigation of device failures (21 CFR 820.198(c))
Document change records, maintained. (21 CFR 820.40(b))
and 10 more

FDA record score

2 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

3 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAINov 17, 20176 x 0.251.5
Inspection classified VAIJan 30, 201510 years or older, so it adds no points0
Warning letter on FDA's dashboard, which does not show close-outsJan 6, 200910 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Hammill Manufacturing Company
Location
MAUMEE, OH (US)
Source
device

Compliance actions

FDA data resources

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