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Fei Fah Medical Manufacturing Pte. Ltd. FDA Record

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

Latest inspection VAI · Dec 9, 2015
Last warning letter 2023

Inspections 2

0 OAI

Recalls 1

0 Class I (0%)

Warning letters 1 Latest Jan 30, 2023

510(k) clearances 0 None on file

Fei Fah Medical Manufacturing Pte. Ltd. has 1 FDA recall, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Fei Fah Medical Manufacturing Pte. Ltd., the most recent on Jan 30, 2023.

What these totals cover: FDA records filed under the name "Fei Fah Medical Manufacturing Pte. Ltd." and its spelling variant "Fei Fah Medical Manufacturing Pte".

Latest recall: D-0104-2027 · Class II · Oct 23, 2026
Latest inspection: Dec 9, 2015 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	1	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	0	Nov 15, 2026	File dated Nov 9, 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

FDA record by year

Fei Fah Medical Manufacturing Pte. Ltd.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Fei Fah Medical Manufacturing Pte. Ltd.: FDA recall records per year

Year	Warning letters	Recall records
2026	0	1
2025	0	0
2024	0	0
2023	1	0
2022	0	0
2021	0	0
2020	0	0
2019	0	0
2018	0	0
2017	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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Fei Fah Medical Manufacturing Pte. Ltd. FDA Warning Letters

1 warning letter on Jan 30, 2023.

Issued	Subject	Issuing office	Close-out letter
Jan 30, 2023 · Letter on fda.gov	CGMP/Finished Pharmaceuticals/Adulterated	Center for Drug Evaluation and Research \| CDER

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 recalls

1 recall record on Oct 23, 2026.

Number	Class	Product	Date
D-0104-2027	Class II	ULTRA STRENTGH, ELECTRIC MIDICATED BALM (menthol 16% and methyl salicylate 32%) packaged in a) Net…	Oct 23, 2026

Recent FDA inspections

2 inspections from Mar 8, 2013 to Dec 9, 2015.

Date	Site	Product	Classification	FEI
Dec 9, 2015	Singapore, Singapore	Drugs	Voluntary Action Indicated (VAI)	3003892002
Mar 8, 2013	Singapore, Singapore	Drugs	Voluntary Action Indicated (VAI)	3003892002

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 Fei Fah Medical Manufacturing Pte. Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jan 30, 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 3003892002	Singapore, Singapore	2	Dec 9, 2015

Fei Fah Medical Manufacturing Pte. Ltd. and the FDA: common questions

Has Fei Fah Medical Manufacturing Pte. Ltd. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Fei Fah Medical Manufacturing Pte. Ltd.. The most recent is dated Jan 30, 2023, with the subject "CGMP/Finished Pharmaceuticals/Adulterated".

Has Fei Fah Medical Manufacturing Pte. Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "Fei Fah Medical Manufacturing Pte. Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Fei Fah Medical Manufacturing Pte. Ltd.?

The most recent FDA inspection on file ended Dec 9, 2015 at Singapore, Singapore and was classified VAI. FDA has 2 inspections of Fei Fah Medical Manufacturing Pte. Ltd. on file.

Has Fei Fah Medical Manufacturing Pte. Ltd. had an FDA recall?

Yes. Fei Fah Medical Manufacturing Pte. Ltd. has 1 FDA recall on record. The most recent started Oct 23, 2026.

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