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SM Biomed Sdn Bhd

FDA Regulatory Profile

SM Biomed Sdn Bhd has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "SM Biomed Sdn Bhd" and its spelling variant "Sm Biomed".

Latest inspection: Jul 28, 2023 · VAI

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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	4	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

SM Biomed Sdn Bhd'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	1	0	0	0	0
2017	0	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.

Recent FDA inspections

4 inspections from Mar 7, 2013 to Jul 28, 2023.

Date	Site	Product	Classification	FEI
Jul 28, 2023	Sungai Petani, Malaysia	Drugs	Voluntary Action Indicated (VAI)	3005983287
Mar 23, 2018	Sungai Petani, Malaysia	Drugs	Voluntary Action Indicated (VAI)	3005983287
Mar 11, 2016	Sungai Petani, Malaysia	Drugs	Voluntary Action Indicated (VAI)	3005983287
Mar 7, 2013	Sungai Petani, Malaysia	Drugs	Voluntary Action Indicated (VAI)	3005983287

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 3005983287	Sungai Petani, Malaysia	4	Jul 28, 2023

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