Jiangsu Hansoh Pharmaceutical Group Co., Ltd FDA Record

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

Jiangsu Hansoh Pharmaceutical Group Co., Ltd has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Jiangsu Hansoh Pharmaceutical Group Co., Ltd" is on file. FDA has published 1 Form 483 for Jiangsu Hansoh Pharmaceutical Group Co., Ltd.

What these totals cover: FDA records filed under the name "Jiangsu Hansoh Pharmaceutical Group Co., Ltd" and its spelling variant "Jiangsu Hansoh Pharmaceutical Group Co".

Latest inspection
Apr 24, 2026 · OAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections4Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Jiangsu Hansoh Pharmaceutical Group Co., Ltd's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Jiangsu Hansoh Pharmaceutical Group Co., Ltd: FDA inspections per year 2017: 0 inspections020172018: 0 inspections020182019: 1 inspections120192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 0 inspections020232024: 0 inspections020242025: 0 inspections020252026: 1 inspections12026
YearInspectionsOAIWarning lettersRecall recordsClass I
202611000
202500000
202400000
202300000
202200000
202100000
202000000
201910000
201800000
201700000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Jiangsu Hansoh Pharmaceutical Group Co., Ltd Form 483s

1 Form 483 published by FDA.

DateDocumentFEI
Apr 24, 20264833008316144

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

4 inspections from Mar 16, 2012 to Apr 24, 2026.

DateSiteProductClassificationFEI
Apr 24, 2026Lianyungang, ChinaDrugsOfficial Action Indicated (OAI)3008316144
Jun 13, 2019Lianyungang, ChinaDrugsVoluntary Action Indicated (VAI)3008316144
Apr 22, 2015Lianyungang, ChinaDrugsNo Action Indicated (NAI)3003663251
Mar 16, 2012Lianyungang, ChinaDrugsVoluntary Action Indicated (VAI)3003663251
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.

FDA-inspected facilities

2 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3008316144Lianyungang, China2Apr 24, 2026
FEI 3003663251Lianyungang, China2Apr 22, 2015

Jiangsu Hansoh Pharmaceutical Group Co., Ltd and the FDA: common questions

Has Jiangsu Hansoh Pharmaceutical Group Co., Ltd received an FDA warning letter?

No FDA warning letter addressed to the name "Jiangsu Hansoh Pharmaceutical Group Co., Ltd" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Jiangsu Hansoh Pharmaceutical Group Co., Ltd received an FDA Form 483?

FDA has published 1 Form 483 for Jiangsu Hansoh Pharmaceutical Group Co., Ltd in its reading room, the most recent dated Apr 24, 2026. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Jiangsu Hansoh Pharmaceutical Group Co., Ltd?

The most recent FDA inspection on file ended Apr 24, 2026 at Lianyungang, China and was classified OAI. FDA has 4 inspections of Jiangsu Hansoh Pharmaceutical Group Co., Ltd on file, 1 of them classified OAI (official action indicated).

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