YS Life Science Co., Ltd. FDA Record

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

YS Life Science Co., Ltd. has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "YS Life Science Co., Ltd." is on file.

What these totals cover: FDA records filed under the name "YS Life Science Co., Ltd." and its spelling variant "Ys Life Science Co".

Latest inspection
Feb 14, 2025 · NAI

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
Inspections5Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

YS Life Science Co., Ltd.: FDA inspections per year 2017: 1 inspections120172018: 1 inspections120182019: 0 inspections020192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 0 inspections020232024: 0 inspections020242025: 1 inspections120252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202400000
202300000
202200000
202100000
202000000
201900000
201810000
201711000

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.

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Recent FDA inspections

5 inspections from Oct 25, 2012 to Feb 14, 2025.

DateSiteProductClassificationFEI
Feb 14, 2025Hwaseong, Korea (The Republic Of)DrugsNo Action Indicated (NAI)3005877120
Sep 14, 2018Hwaseong, Korea (The Republic Of)DrugsNo Action Indicated (NAI)3005877120
Sep 15, 2017Hwaseong, Korea (The Republic Of)DrugsOfficial Action Indicated (OAI)3005877120
Dec 11, 2015Hwaseong, Korea (The Republic Of)DrugsVoluntary Action Indicated (VAI)3005877120
Oct 25, 2012Hwaseong, Korea (The Republic Of)DrugsVoluntary Action Indicated (VAI)3005877120
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 3005877120Hwaseong, Korea (The Republic Of)5Feb 14, 2025

YS Life Science Co., Ltd. and the FDA: common questions

Has YS Life Science Co., Ltd. received an FDA warning letter?

No FDA warning letter addressed to the name "YS Life Science 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 YS Life Science Co., Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "YS Life Science Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect YS Life Science Co., Ltd.?

The most recent FDA inspection on file ended Feb 14, 2025 at Hwaseong, Korea (The Republic Of) and was classified NAI. FDA has 5 inspections of YS Life Science 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.