TTY Biopharm Company Limited Lioudu Factory FDA Record

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

  • Latest inspection VAI · Apr 22, 2025
  • No warning letters matched by name
Inspections 1 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

TTY Biopharm Company Limited Lioudu Factory has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "TTY Biopharm Company Limited Lioudu Factory" is on file.

What these totals cover: FDA records filed under the name "TTY Biopharm Company Limited Lioudu Factory".

Latest inspection
Apr 22, 2025 · VAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 11, 2026 (checked Nov 15, 2026, unchanged)File dated Nov 10, 2026Current
510(k) clearances0Nov 15, 2026File dated Nov 9, 2026Current
Inspections1Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

1 inspection on Apr 22, 2025.

DateSiteProductClassificationFEI
Apr 22, 2025Keelung City, TaiwanDrugsVoluntary Action Indicated (VAI)3015497585
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 3015497585Keelung City, Taiwan1Apr 22, 2025

TTY Biopharm Company Limited Lioudu Factory and the FDA: common questions

Has TTY Biopharm Company Limited Lioudu Factory received an FDA warning letter?

No FDA warning letter addressed to the name "TTY Biopharm Company Limited Lioudu Factory" 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 TTY Biopharm Company Limited Lioudu Factory received an FDA Form 483?

FDA has not published a Form 483 for "TTY Biopharm Company Limited Lioudu Factory" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect TTY Biopharm Company Limited Lioudu Factory?

The most recent FDA inspection on file ended Apr 22, 2025 at Keelung City, Taiwan and was classified VAI. FDA has 1 inspection of TTY Biopharm Company Limited Lioudu Factory on file.

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