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Reka Health Pte Ltd — FDA Facility Profile

FEI 3008687164

Reka Health Pte Ltd is an FDA-inspected facility (FEI 3008687164) located in Singapore, SG. RegDataLab tracks 1 FDA inspection and 1 compliance action at this facility.

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What FDA found at this site

Latest inspection
Aug 21, 2014: Official Action Indicated (OAI)
Inspections on record
1 (1 OAI)
Last OAI inspection
Aug 21, 2014
Warning letters
1 listed by FDA for this FEI, latest Dec 19, 2014

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
Aug 21, 2014Official Action Indicated (OAI)DHR - not or inadequately maintained (21 CFR 820.184)
Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Design review - Lack of or inadequate procedures (21 CFR 820.30(e))
Design validation- Lack of or inadequate procedures (21 CFR 820.30(g))
and 2 more

Facility details

Company
Reka Health Pte Ltd
Location
Singapore (SG)
Source
inspections

Compliance actions

FDA data resources

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