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F.P. Rubinstein Y Cia S.R.L.

FDA Regulatory Profile

F.P. Rubinstein Y Cia S.R.L. has 0 FDA recalls, 1 inspection, 1 510(k) clearance and 2 compliance actions on record.

What these totals cover: FDA records filed under the name "F.P. Rubinstein Y Cia S.R.L." and its spelling variant "F.P. Rubinstein Y Cia".

Latest inspection: Oct 17, 2014 · OAI
Latest 510(k): Sep 3, 2008

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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	1	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	1	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	2	Nov 2, 2026	Newest record Oct 29, 2026	Current

Recent FDA inspections

1 inspection on Oct 17, 2014.

Date	Site	Product	Classification	FEI
Oct 17, 2014	Cordoba, Argentina	Devices	Official Action Indicated (OAI)	3003735408

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 2 compliance actions under F.P. Rubinstein Y Cia S.R.L.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, May 5, 2016.

Individual 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 3003735408	Cordoba, Argentina	1	Oct 17, 2014

Recent 510(k) clearances

1 510(k) clearance on Sep 3, 2008.

K-Number	Device	Date
K073317	STARLIGHT, MODEL PD9012	Sep 3, 2008

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