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HEBEI PUKANG MEDICAL INSTRUMENTS CO.,LTD FDA Inspection Record

FEI 3007744192 · Inspections, Form 483s, warning letters and import refusals

HEBEI PUKANG MEDICAL INSTRUMENTS CO.,LTD is an FDA-registered facility (FEI 3007744192) located in Baoding Hebei, CN. RegDataLab tracks 1 FDA inspection and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Jan 12, 2017: Official Action Indicated (OAI)
Inspections on record
1 (1 OAI)
Last OAI inspection
Jan 12, 2017
Warning letters
1 listed by FDA for this FEI, latest Mar 29, 2017
Import refusals
10 or more

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
Jan 12, 2017Official Action Indicated (OAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Quality audits - Lack of or inadequate procedures (21 CFR 820.22)
Design control - no procedures (21 CFR 820.30(a))
Lack of or inadequate procedures (21 CFR 820.100(a))
and 4 more

FDA record score

15 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 15, 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.

2 records behind this number
RecordDatePoints x age weightAdds
Warning letter on FDA's dashboard, which does not show close-outsMar 29, 201730 x 0.257.5
Inspection classified OAIJan 12, 201730 x 0.257.5

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 15, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 15, 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 15, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 15, 2026Newest record Nov 5, 2026Current

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Facility details

Company
Hebei Pukang Medical Instruments Co., Ltd.
Location
Baoding Hebei (CN)
Source
device

Compliance actions

Import refusals

FDA data resources

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