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Gem Foods International, Inc. FDA Record

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

Latest inspection NAI · Nov 12, 2022
No warning letters matched by name

Inspections 2

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Gem Foods International, Inc. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Gem Foods International, Inc." is on file.

What these totals cover: FDA records filed under the name "Gem Foods International, Inc." and its spelling variant "Gem Foods International".

Latest inspection: Nov 12, 2022 · NAI

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 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Gem Foods International, Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Gem Foods International, Inc.: FDA inspections per year

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	0	0	0	0	0
2022	1	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 Oct 26, 2017 to Nov 12, 2022.

Date	Site	Product	Classification	FEI
Nov 12, 2022	Caloocan City North, Philippines	Food/Cosmetics	No Action Indicated (NAI)	3005358956
Oct 26, 2017	Laguna, Philippines	Food/Cosmetics	No Action Indicated (NAI)	3005132483

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

2 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3005358956	Caloocan City North, Philippines	1	Nov 12, 2022
FEI 3005132483	Laguna, Philippines	1	Oct 26, 2017

Gem Foods International, Inc. and the FDA: common questions

Has Gem Foods International, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Gem Foods International, Inc." 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 Gem Foods International, Inc. received an FDA Form 483?

FDA has not published a Form 483 for "Gem Foods International, Inc." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Gem Foods International, Inc.?

The most recent FDA inspection on file ended Nov 12, 2022 at Caloocan City North, Philippines and was classified NAI. FDA has 2 inspections of Gem Foods International, Inc. on file.

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