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The Pastene Companies Ltd. FDA Inspection Record

FEI 1213352 · Inspections, Form 483s, warning letters and import refusals

The Pastene Companies Ltd. is an FDA-inspected facility (FEI 1213352) located in Canton, MA, US. RegDataLab tracks 5 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Apr 7, 2025: No Action Indicated (NAI)
Inspections on record
5 (1 VAI, 4 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
1, latest Apr 10, 2014

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Apr 7, 2025No Action Indicated (NAI)No citations listed
Sep 16, 2019No Action Indicated (NAI)No citations listed
Sep 27, 2017Voluntary Action Indicated (VAI)No citations listed
Aug 28, 2012No Action Indicated (NAI)No citations listed
Jul 7, 2010No Action Indicated (NAI)No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Apr 10, 2014Class IIF-1889-2014Pastene MAFALDINE 5, 16 oz cellophane bag Imported from Italy. Imported by the Pastene… and 23 more products
Semolina pasta fails to declare the allergen"wheat"

FDA record score

2 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

2 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAISep 27, 20176 x 0.251.5
Class II recall F-1889-2014, this FEI as the recalling firmApr 10, 201410 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
The Pastene Companies Ltd.
Location
Canton, MA (US)
Source
inspections

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.