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Reka Health Pte Ltd FDA Record

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

Reka Health Pte Ltd has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Reka Health Pte Ltd, the most recent on Dec 19, 2014.

What these totals cover: FDA records filed under the name "Reka Health Pte Ltd" and its spelling variant "Reka Health".

Latest inspection: Aug 21, 2014 · OAI

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	1	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

Reka Health Pte Ltd FDA Warning Letters

1 warning letter on Dec 19, 2014.

Issued	Subject	Issuing office	Close-out letter
Dec 19, 2014

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

1 inspection on Aug 21, 2014.

Date	Site	Product	Classification	FEI
Aug 21, 2014	Singapore, Singapore	Devices	Official Action Indicated (OAI)	3008687164

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 Reka Health Pte Ltd: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Dec 19, 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.

Facility	Location	Inspections	Latest
FEI 3008687164	Singapore, Singapore	1	Aug 21, 2014

Reka Health Pte Ltd and the FDA: common questions

Has Reka Health Pte Ltd received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Reka Health Pte Ltd. The most recent is dated Dec 19, 2014.

Has Reka Health Pte Ltd received an FDA Form 483?

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

When did the FDA last inspect Reka Health Pte Ltd?

The most recent FDA inspection on file ended Aug 21, 2014 at Singapore, Singapore and was classified OAI. FDA has 1 inspection of Reka Health Pte Ltd on file, 1 of them classified OAI (official action indicated).

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