Scinopharm Taiwan, Ltd.

FDA Regulatory Profile

Scinopharm Taiwan, Ltd. has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Scinopharm Taiwan, Ltd." and its spelling variant "Scinopharm Taiwan".

Latest inspection
Jun 23, 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
Inspections8Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Scinopharm Taiwan, Ltd.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Scinopharm Taiwan, Ltd.: FDA inspections per year 2017: 1 inspections120172018: 0 inspections020182019: 1 inspections120192020: 0 inspections020202021: 0 inspections020212022: 1 inspections120222023: 0 inspections020232024: 1 inspections120242025: 0 inspections020252026: 1 inspections12026
YearInspectionsOAIWarning lettersRecall recordsClass I
202611000
202500000
202410000
202300000
202210000
202100000
202000000
201910000
201800000
201710000

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.

Recent FDA inspections

8 inspections from Oct 23, 2008 to Jun 23, 2026.

DateSiteProductClassificationFEI
Jun 23, 2026Tainan City, TaiwanDrugsOfficial Action Indicated (OAI)3002840477
Mar 21, 2024Tainan City, TaiwanDevicesNo Action Indicated (NAI)3002840477
Oct 25, 2022Tainan City, TaiwanDrugsNo Action Indicated (NAI)3002840477
May 17, 2019Tainan City, TaiwanDrugsNo Action Indicated (NAI)3002840477
Feb 10, 2017Tainan City, TaiwanDrugsNo Action Indicated (NAI)3002840477
Mar 27, 2015Tainan City, TaiwanDrugsNo Action Indicated (NAI)3002840477
Mar 29, 2012Tainan City, TaiwanDrugsVoluntary Action Indicated (VAI)3002840477
Oct 23, 2008Tainan City, TaiwanDrugsVoluntary Action Indicated (VAI)3002840477
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

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3002840477Tainan City, Taiwan8Jun 23, 2026

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