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P.T. Sankei Medical Industries FDA Record

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

Latest inspection OAI · May 11, 2023
Last warning letter 2023

Inspections 2

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Sep 19, 2023

510(k) clearances 0 None on file

P.T. Sankei Medical Industries has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to P.T. Sankei Medical Industries, the most recent on Sep 19, 2023.

What these totals cover: FDA records filed under the name "P.T. Sankei Medical Industries".

Latest inspection: May 11, 2023 · OAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	2	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

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P.T. Sankei Medical Industries FDA Warning Letters

1 warning letter on Sep 19, 2023.

Issued	Subject	Issuing office	Close-out letter
Sep 19, 2023 · Letter on fda.gov	CGMP/QSR/Medical Devices/Adulterated	Center for Devices and Radiological Health

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

2 inspections from Apr 14, 2016 to May 11, 2023.

Date	Site	Product	Classification	FEI
May 11, 2023	Serang, Indonesia	Devices	Official Action Indicated (OAI)	3001576493
Apr 14, 2016	Serang, Indonesia	Devices	Voluntary Action Indicated (VAI)	3001576493

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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under P.T. Sankei Medical Industries: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Sep 19, 2023.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3001576493	Serang, Indonesia	2	May 11, 2023

P.T. Sankei Medical Industries and the FDA: common questions

Has P.T. Sankei Medical Industries received an FDA warning letter?

Yes. FDA has issued 1 warning letter to P.T. Sankei Medical Industries. The most recent is dated Sep 19, 2023, with the subject "CGMP/QSR/Medical Devices/Adulterated".

Has P.T. Sankei Medical Industries received an FDA Form 483?

FDA has not published a Form 483 for "P.T. Sankei Medical Industries" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect P.T. Sankei Medical Industries?

The most recent FDA inspection on file ended May 11, 2023 at Serang, Indonesia and was classified OAI. FDA has 2 inspections of P.T. Sankei Medical Industries on file, 1 of them classified OAI (official action indicated).

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