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BSP Pharmaceuticals SpA FDA Record

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

Latest inspection VAI · Feb 21, 2025
No warning letters matched by name

Inspections 7

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

BSP Pharmaceuticals SpA has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "BSP Pharmaceuticals SpA" is on file.

What these totals cover: FDA records filed under the name "BSP Pharmaceuticals SpA" and its spelling variant "Bsp Pharmaceuticals".

Latest inspection: Feb 21, 2025 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	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	7	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

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

BSP Pharmaceuticals SpA: 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	0	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	1	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

7 inspections from Nov 12, 2010 to Feb 21, 2025.

Date	Site	Product	Classification	FEI
Feb 21, 2025	Latina, Italy	Drugs	Voluntary Action Indicated (VAI)	3007255826
Nov 12, 2021	Latina, Italy	Drugs	Voluntary Action Indicated (VAI)	3007255826
Oct 20, 2017	Latina, Italy	Drugs	Voluntary Action Indicated (VAI)	3007255826
Dec 16, 2016	Latina, Italy	Drugs	Voluntary Action Indicated (VAI)	3007255826
Jun 26, 2015	Latina, Italy	Drugs	Voluntary Action Indicated (VAI)	3007255826
Dec 5, 2012	Latina, Italy	Drugs	Voluntary Action Indicated (VAI)	3007255826
Nov 12, 2010	Latina, Italy	Drugs	No Action Indicated (NAI)	3007255826

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 3007255826	Latina, Italy	7	Feb 21, 2025

BSP Pharmaceuticals SpA and the FDA: common questions

Has BSP Pharmaceuticals SpA received an FDA warning letter?

No FDA warning letter addressed to the name "BSP Pharmaceuticals SpA" 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 BSP Pharmaceuticals SpA received an FDA Form 483?

FDA has not published a Form 483 for "BSP Pharmaceuticals SpA" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect BSP Pharmaceuticals SpA?

The most recent FDA inspection on file ended Feb 21, 2025 at Latina, Italy and was classified VAI. FDA has 7 inspections of BSP Pharmaceuticals SpA on file.

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