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DDP Specialty Electronic Materials US 9, LLC FDA Inspection Record

FEI 1816403 · Inspections, Form 483s, warning letters and import refusals

DDP Specialty Electronic Materials US 9, LLC is an FDA-inspected facility (FEI 1816403) located in Hemlock, MI, US. RegDataLab tracks 7 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Apr 16, 2025: No Action Indicated (NAI)
Inspections on record
7 (6 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
Recalls as the recalling firm
1, latest Dec 14, 2010

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
Apr 16, 2025No Action Indicated (NAI)No citations listed
Nov 7, 2018Voluntary Action Indicated (VAI)No citations listed
Jun 1, 2017Voluntary Action Indicated (VAI)Lack of or inadequate procedures (21 CFR 820.100(a))
Jan 24, 2014Voluntary Action Indicated (VAI)No citations listed
May 18, 2012Voluntary Action Indicated (VAI)No citations listed
Jun 29, 2011Voluntary Action Indicated (VAI)No citations listed
Jul 8, 2009Voluntary Action Indicated (VAI)No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Dec 14, 2010Class IID-1577-2011Dow Corning Q7-2587 and Q7-2587N (both generally referred to as Q7-2587), 30% Simethicone…
Microbial Contamination of Non Sterile Product; mold found in gasket area of drum lid

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
DDP Specialty Electronic Materials US 9, LLC
Location
Hemlock, MI (US)
Source
inspections

FDA data resources

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