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Thai Hospital Products Co., Ltd. FDA Record

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

Thai Hospital Products Co., Ltd. has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Thai Hospital Products Co., Ltd." is on file.

What these totals cover: FDA records filed under the name "Thai Hospital Products Co., Ltd." and its spelling variant "Thai Hospital Products Co".

Latest inspection: Jun 22, 2023 · VAI
Latest 510(k): Aug 29, 1991

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	1	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	2	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

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

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	1	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	0	0	0	0	0
2017	1	0	0	0	0

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

2 inspections from Jan 26, 2017 to Jun 22, 2023.

Date	Site	Product	Classification	FEI
Jun 22, 2023	Pakkret, Thailand	Devices	Voluntary Action Indicated (VAI)	3003024808
Jan 26, 2017	Pakkret, Thailand	Devices	No Action Indicated (NAI)	3003024808

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.

Facility	Location	Inspections	Latest
FEI 3003024808	Pakkret, Thailand	2	Jun 22, 2023

Recent 510(k) clearances

1 510(k) clearance on Aug 29, 1991.

K-Number	Device	Date
K911334	MASK, SURGICAL APPAREL	Aug 29, 1991

Thai Hospital Products Co., Ltd. and the FDA: common questions

Has Thai Hospital Products Co., Ltd. received an FDA warning letter?

No FDA warning letter addressed to the name "Thai Hospital Products 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 Thai Hospital Products Co., Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "Thai Hospital Products Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Thai Hospital Products Co., Ltd.?

The most recent FDA inspection on file ended Jun 22, 2023 at Pakkret, Thailand and was classified VAI. FDA has 2 inspections of Thai Hospital Products Co., Ltd. on file.

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