Sterex Electrolysis Int Ltd FDA Record

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

  • Latest inspection NAI · Nov 6, 2014
  • Last warning letter 2013
Inspections 2 1 OAI
Recalls 0 0 Class I
Warning letters 1 Latest Jun 24, 2013
510(k) clearances 0 None on file

Sterex Electrolysis Int Ltd has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Sterex Electrolysis Int Ltd, the most recent on Jun 24, 2013.

What these totals cover: FDA records filed under the name "Sterex Electrolysis Int Ltd" and its spelling variant "Sterex Electrolysis Int".

Latest inspection
Nov 6, 2014 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 11, 2026 (checked Nov 15, 2026, unchanged)File dated Nov 10, 2026Current
510(k) clearances0Nov 15, 2026File dated Nov 9, 2026Current
Inspections2Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

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Sterex Electrolysis Int Ltd FDA Warning Letters

1 warning letter on Jun 24, 2013.

IssuedSubjectIssuing officeClose-out letter
Jun 24, 2013 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

2 inspections from Feb 14, 2013 to Nov 6, 2014.

DateSiteProductClassificationFEI
Nov 6, 2014Birmingham, United KingdomDevicesNo Action Indicated (NAI)1000439607
Feb 14, 2013Birmingham, United KingdomDevicesOfficial Action Indicated (OAI)1000439607
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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Sterex Electrolysis Int Ltd: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jun 24, 2013.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 1000439607Birmingham, United Kingdom2Nov 6, 2014

Sterex Electrolysis Int Ltd and the FDA: common questions

Has Sterex Electrolysis Int Ltd received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Sterex Electrolysis Int Ltd. The most recent is dated Jun 24, 2013.

Has Sterex Electrolysis Int Ltd received an FDA Form 483?

FDA has not published a Form 483 for "Sterex Electrolysis Int Ltd" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Sterex Electrolysis Int Ltd?

The most recent FDA inspection on file ended Nov 6, 2014 at Birmingham, United Kingdom and was classified NAI. FDA has 2 inspections of Sterex Electrolysis Int Ltd on file, 1 of them classified OAI (official action indicated).

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