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Sharplight Technologies — FDA Facility Profile

FEI 3009352034

Sharplight Technologies is an FDA-inspected facility (FEI 3009352034) located in Rishon Le-Tsiyon, IL. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.

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What FDA found at this site

Latest inspection
Feb 14, 2019: Voluntary Action Indicated (VAI)
Inspections on record
2 (2 VAI)
Last OAI inspection
None on record
Warning letters
1 listed by FDA for this FEI, latest Nov 25, 2013

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
Feb 14, 2019Voluntary Action Indicated (VAI)No citations listed
Jun 13, 2013Voluntary Action Indicated (VAI)DHR - not or inadequately maintained (21 CFR 820.184)
Procedures not adequately established or maintained (21 CFR 820.40)
Design plans- updated (21 CFR 820.30(b))
Design review - Lack of or inadequate procedures (21 CFR 820.30(e))
and 8 more

Facility details

Company
Sharplight Technologies
Location
Rishon Le-Tsiyon (IL)
Source
inspections

Compliance actions

FDA data resources

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