LockDown Medical Ltd. FDA Record

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

  • Latest inspection NAI · Jul 3, 2023
  • Last warning letter 2014
Inspections 2 1 OAI
Recalls 0 0 Class I
Warning letters 1 Latest Sep 11, 2014
510(k) clearances 0 None on file

LockDown Medical Ltd. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to LockDown Medical Ltd., the most recent on Sep 11, 2014.

What these totals cover: FDA records filed under the name "LockDown Medical Ltd." and its spelling variant "Lockdown Medical".

Latest inspection
Jul 3, 2023 · 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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LockDown Medical Ltd. FDA Warning Letters

1 warning letter on Sep 11, 2014.

IssuedSubjectIssuing officeClose-out letter
Sep 11, 2014 · 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 Jun 5, 2014 to Jul 3, 2023.

DateSiteProductClassificationFEI
Jul 3, 2023Redditch, United KingdomDevicesNo Action Indicated (NAI)3008237817
Jun 5, 2014Redditch, United KingdomDevicesOfficial Action Indicated (OAI)3008237817
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 LockDown Medical Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Sep 11, 2014.

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 3008237817Redditch, United Kingdom2Jul 3, 2023

LockDown Medical Ltd. and the FDA: common questions

Has LockDown Medical Ltd. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to LockDown Medical Ltd.. The most recent is dated Sep 11, 2014.

Has LockDown Medical Ltd. received an FDA Form 483?

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

When did the FDA last inspect LockDown Medical Ltd.?

The most recent FDA inspection on file ended Jul 3, 2023 at Redditch, United Kingdom and was classified NAI. FDA has 2 inspections of LockDown Medical 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.