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Heartsine Technologies Inc FDA Inspection Record

FEI 3004018643 · Inspections, Form 483s, warning letters and import refusals

Heartsine Technologies Inc is an FDA-inspected facility (FEI 3004018643) located in Newtown, PA, US. RegDataLab tracks 5 FDA inspections and 2 compliance actions at this facility.

What FDA found at this site

Latest inspection
May 3, 2018: No Action Indicated (NAI)
Inspections on record
5 (2 OAI, 2 VAI, 1 NAI)
Last OAI inspection
Aug 22, 2013
Warning letters
2 listed by FDA for this FEI, latest Feb 3, 2014
Import refusals
1

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
May 3, 2018No Action Indicated (NAI)No citations listed
Sep 16, 2014Voluntary Action Indicated (VAI)No citations listed
Aug 22, 2013Official Action Indicated (OAI)Software validation for automated processes (21 CFR 820.70(i))
Design validation - user needs and intended uses (21 CFR 820.30(g))
Management review - Lack of or inadequate procedures (21 CFR 820.20(c))
Documentation (21 CFR 820.100(b))
and 2 more
Mar 16, 2010Voluntary Action Indicated (VAI)Approval, inadequate purchasing data (21 CFR 820.50(b))
Aug 4, 2009Official Action Indicated (OAI)General (21 CFR 820.198(a))
Records not current (21 CFR 821.25(b))
Missing data (21 CFR 821.25(c)(1))
Quality assurance procedures: 6-month & annual audits (21 CFR 821.25(c)(3))

FDA record score

0 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

6 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAISep 16, 201410 years or older, so it adds no points0
Warning letter on FDA's dashboard, which does not show close-outsFeb 3, 201410 years or older, so it adds no points0
Inspection classified OAIAug 22, 201310 years or older, so it adds no points0
Inspection classified VAIMar 16, 201010 years or older, so it adds no points0
Warning letter on FDA's dashboard, which does not show close-outsDec 10, 200910 years or older, so it adds no points0
Inspection classified OAIAug 4, 200910 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Heartsine Technologies Inc
Location
Newtown, PA (US)
Source
inspections

Compliance actions

Import refusals

FDA data resources

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