Home / Companies / Prolac, Inc.

Prolac, Inc. FDA Record

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

Prolac, Inc. has 0 FDA recalls, 4 inspections, 1 510(k) clearance and 1 compliance action on record. FDA has issued 1 warning letter to Prolac, Inc., the most recent on Jan 12, 2011.

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

Latest inspection: Sep 5, 2012 · NAI
Latest 510(k): Aug 16, 1993

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

Reviewing Prolac, Inc. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Prolac, Inc. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Prolac, Inc. FDA Warning Letters

1 warning letter on Jan 12, 2011.

Issued	Subject	Issuing office	Close-out letter
Jan 12, 2011 · Record page

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

4 inspections from Sep 21, 2009 to Sep 5, 2012.

Date	Site	Product	Classification	FEI
Sep 5, 2012	Bayamon, PR	Food/Cosmetics	No Action Indicated (NAI)	2619869
May 10, 2011	Bayamon, PR	Food/Cosmetics	Official Action Indicated (OAI)	2619869
Sep 9, 2010	Bayamon, PR	Food/Cosmetics	Voluntary Action Indicated (VAI)	2619869
Sep 21, 2009	Bayamon, PR	Food/Cosmetics	Voluntary Action Indicated (VAI)	2619869

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 Prolac, Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jan 12, 2011.

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 2619869	Bayamon, PR	4	Sep 5, 2012

Recent 510(k) clearances

1 510(k) clearance on Aug 16, 1993.

K-Number	Device	Date
K930238	BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS	Aug 16, 1993

Prolac, Inc. and the FDA: common questions

Has Prolac, Inc. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Prolac, Inc.. The most recent is dated Jan 12, 2011.

Has Prolac, Inc. received an FDA Form 483?

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

When did the FDA last inspect Prolac, Inc.?

The most recent FDA inspection on file ended Sep 5, 2012 at Bayamon, PR and was classified NAI. FDA has 4 inspections of Prolac, Inc. on file, 1 of them classified OAI (official action indicated).

Need more than this page shows? Ask about Prolac, Inc. in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.