Sheng-Han Kuo, MD FDA Record

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

Sheng-Han Kuo, MD has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Sheng-Han Kuo, MD" is on file.

What these totals cover: FDA records filed under the name "Sheng-Han Kuo, MD".

Latest inspection
Apr 18, 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
Inspections1Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

1 inspection on Apr 18, 2025.

DateSiteProductClassificationFEI
Apr 18, 2025New York, NYDrugsNo Action Indicated (NAI)3035553227
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 3035553227New York, NY1Apr 18, 2025

Sheng-Han Kuo, MD and the FDA: common questions

Has Sheng-Han Kuo, MD received an FDA warning letter?

No FDA warning letter addressed to the name "Sheng-Han Kuo, MD" 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 Sheng-Han Kuo, MD received an FDA Form 483?

FDA has not published a Form 483 for "Sheng-Han Kuo, MD" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Sheng-Han Kuo, MD?

The most recent FDA inspection on file ended Apr 18, 2025 at New York, NY and was classified NAI. FDA has 1 inspection of Sheng-Han Kuo, MD on file.

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