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PROSANA DISTRIBUCIONES SA DE CV FDA Record

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

PROSANA DISTRIBUCIONES SA DE CV has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to PROSANA DISTRIBUCIONES SA DE CV, the most recent on Dec 21, 2017.

What these totals cover: FDA records filed under the name "PROSANA DISTRIBUCIONES SA DE CV".

Latest inspection: Mar 9, 2017 · OAI

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	1	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

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PROSANA DISTRIBUCIONES SA DE CV FDA Warning Letters

1 warning letter on Dec 21, 2017.

Issued	Subject	Issuing office	Close-out letter
Dec 21, 2017

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 FDA inspections

1 inspection on Mar 9, 2017.

Date	Site	Product	Classification	FEI
Mar 9, 2017	Ciudad De Mexico, Mexico	Drugs	Official Action Indicated (OAI)	3011473501

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 PROSANA DISTRIBUCIONES SA DE CV: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Dec 21, 2017.

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 3011473501	Ciudad De Mexico, Mexico	1	Mar 9, 2017

PROSANA DISTRIBUCIONES SA DE CV and the FDA: common questions

Has PROSANA DISTRIBUCIONES SA DE CV received an FDA warning letter?

Yes. FDA has issued 1 warning letter to PROSANA DISTRIBUCIONES SA DE CV. The most recent is dated Dec 21, 2017.

Has PROSANA DISTRIBUCIONES SA DE CV received an FDA Form 483?

FDA has not published a Form 483 for "PROSANA DISTRIBUCIONES SA DE CV" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect PROSANA DISTRIBUCIONES SA DE CV?

The most recent FDA inspection on file ended Mar 9, 2017 at Ciudad De Mexico, Mexico and was classified OAI. FDA has 1 inspection of PROSANA DISTRIBUCIONES SA DE CV on file, 1 of them classified OAI (official action indicated).

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