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SILEX MEDICAL, LLC FDA Inspection Record

FEI 3005110411 · Inspections, Form 483s, warning letters and import refusals

SILEX MEDICAL, LLC is an FDA-registered facility (FEI 3005110411) located in SOUTHINGTON, CT, US. RegDataLab tracks 4 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Apr 23, 2025: Voluntary Action Indicated (VAI)
Inspections on record
4 (3 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 Jan 9, 2024

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 23, 2025Voluntary Action Indicated (VAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Lack of or inadequate final acceptance procedures (21 CFR 820.80(d))
Lack of or inadequate procedures (21 CFR 820.100(a))
Nonconforming product, Lack of or inadequate procedures (21 CFR 820.90(a))
and 2 more
Jun 11, 2019No Action Indicated (NAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Lack of or inadequate procedures (21 CFR 820.100(a))
Calibration, Inspection, etc. Procedures Lack of or Inadequ (21 CFR 820.72(a))
Nov 18, 2015Voluntary Action Indicated (VAI)Design validation- Lack of or inadequate procedures (21 CFR 820.30(g))
Aug 22, 2012Voluntary Action Indicated (VAI)Design changes - Lack of or Inadequate Procedures (21 CFR 820.30(i))
Complaints (21 CFR 820.198(a))

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
Jan 9, 2024Class IIZ-1893-2025Signature Laparoscopic Instruments, Dolphin Nose Grasper with Rotating Shaft and Monopolar… and 7 more products
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of…

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
Silex Medical, LLC
Location
SOUTHINGTON, CT (US)
Source
device

FDA data resources

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