Silimed Industria De Implantes Ltda FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Silimed Industria De Implantes Ltda has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Silimed Industria De Implantes Ltda" is on file.

What these totals cover: FDA records filed under the name "Silimed Industria De Implantes Ltda".

Latest inspection
Feb 29, 2024 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections3Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

3 inspections from Nov 6, 2009 to Feb 29, 2024.

DateSiteProductClassificationFEI
Feb 29, 2024Rio De Janeiro, BrazilDevicesNo Action Indicated (NAI)3029687827
Mar 14, 2013Rio De Janeiro, BrazilDevicesNo Action Indicated (NAI)3002808187
Nov 6, 2009Rio De Janeiro, BrazilDevicesNo Action Indicated (NAI)3002808187
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

2 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3029687827Rio De Janeiro, Brazil1Feb 29, 2024
FEI 3002808187Rio De Janeiro, Brazil2Mar 14, 2013

Silimed Industria De Implantes Ltda and the FDA: common questions

Has Silimed Industria De Implantes Ltda received an FDA warning letter?

No FDA warning letter addressed to the name "Silimed Industria De Implantes Ltda" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Silimed Industria De Implantes Ltda received an FDA Form 483?

FDA has not published a Form 483 for "Silimed Industria De Implantes Ltda" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Silimed Industria De Implantes Ltda?

The most recent FDA inspection on file ended Feb 29, 2024 at Rio De Janeiro, Brazil and was classified NAI. FDA has 3 inspections of Silimed Industria De Implantes Ltda on file.

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