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SPI Pharma, Inc. FDA Record

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

Latest inspection NAI · Sep 26, 2025
No warning letters matched by name

Inspections 15

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

SPI Pharma, Inc. has 0 FDA recalls, 15 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "SPI Pharma, Inc." is on file.

What these totals cover: FDA records filed under the name "SPI Pharma, Inc." and its spelling variant "Spi Pharma".

Latest inspection: Sep 26, 2025 · 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	15	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

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

SPI Pharma, Inc.: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	1	0	0	0	0
2024	2	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	1	0	0	0	0
2018	1	0	0	0	0
2017	2	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

15 inspections from Sep 29, 2009 to Sep 26, 2025.

Date	Site	Product	Classification	FEI
Sep 26, 2025	Grand Haven, MI	Drugs	No Action Indicated (NAI)	1833292
Apr 26, 2024	Septemes Les Vallons, France	Drugs	Voluntary Action Indicated (VAI)	3003755498
Feb 1, 2024	Lewes, DE	Drugs	No Action Indicated (NAI)	2515692
Apr 29, 2019	Grand Haven, MI	Drugs	No Action Indicated (NAI)	1833292
Jun 29, 2018	Septemes Les Vallons, France	Drugs	Voluntary Action Indicated (VAI)	3003755498
Sep 28, 2017	Lewes, DE	Food/Cosmetics	No Action Indicated (NAI)	2515692
Mar 6, 2017	Grand Haven, MI	Food/Cosmetics	No Action Indicated (NAI)	1833292
Aug 24, 2016	Lewes, DE	Drugs	No Action Indicated (NAI)	2515692
Feb 12, 2016	Septemes Les Vallons, France	Drugs	Voluntary Action Indicated (VAI)	3003755498
Nov 19, 2013	Grand Haven, MI	Drugs	Voluntary Action Indicated (VAI)	1833292
Feb 14, 2013	Septemes Les Vallons, France	Drugs	Voluntary Action Indicated (VAI)	3003755498
Sep 7, 2012	Lewes, DE	Drugs	No Action Indicated (NAI)	2515692
May 4, 2011	Grand Haven, MI	Drugs	No Action Indicated (NAI)	1833292
May 12, 2010	Grand Haven, MI	Drugs	No Action Indicated (NAI)	1833292
Sep 29, 2009	Septemes Les Vallons, France	Drugs	Voluntary Action Indicated (VAI)	3003755498

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

3 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 1833292	Grand Haven, MI	6	Sep 26, 2025
FEI 3003755498	Septemes Les Vallons, France	5	Apr 26, 2024
FEI 2515692	Lewes, DE	4	Feb 1, 2024

SPI Pharma, Inc. and the FDA: common questions

Has SPI Pharma, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "SPI Pharma, 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 SPI Pharma, Inc. received an FDA Form 483?

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

When did the FDA last inspect SPI Pharma, Inc.?

The most recent FDA inspection on file ended Sep 26, 2025 at Grand Haven, MI and was classified NAI. FDA has 15 inspections of SPI Pharma, Inc. on file.

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