Halo Pharmaceutical, Inc. D/B/A Cambrex Whippany FDA Record

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

  • Latest inspection NAI · Dec 8, 2025
  • No warning letters matched by name
Inspections 13 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

Halo Pharmaceutical, Inc. D/B/A Cambrex Whippany has 0 FDA recalls, 13 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Halo Pharmaceutical, Inc. D/B/A Cambrex Whippany" is on file.

What these totals cover: FDA records filed under the name "Halo Pharmaceutical, Inc. D/B/A Cambrex Whippany".

Latest inspection
Dec 8, 2025 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections13Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Halo Pharmaceutical, Inc. D/B/A Cambrex Whippany's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Halo Pharmaceutical, Inc. D/B/A Cambrex Whippany: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202400000
202310000
202200000
202100000
202000000
201910000
201810000
201720000

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

13 inspections from Jun 10, 2009 to Dec 8, 2025.

DateSiteProductClassificationFEI
Dec 8, 2025Whippany, NJVeterinaryNo Action Indicated (NAI)2211084
Feb 17, 2023Whippany, NJDrugsNo Action Indicated (NAI)2211084
Dec 20, 2019Whippany, NJDrugsVoluntary Action Indicated (VAI)2211084
May 30, 2018Whippany, NJDrugsVoluntary Action Indicated (VAI)2211084
Aug 24, 2017Whippany, NJDrugsNo Action Indicated (NAI)2211084
Mar 20, 2017Whippany, NJDrugsVoluntary Action Indicated (VAI)2211084
May 27, 2016Whippany, NJDrugsNo Action Indicated (NAI)2211084
Apr 24, 2015Whippany, NJDrugsVoluntary Action Indicated (VAI)2211084
May 12, 2014Whippany, NJDrugsVoluntary Action Indicated (VAI)2211084
Nov 20, 2012Whippany, NJDrugsNo Action Indicated (NAI)2211084
Jun 21, 2011Whippany, NJDrugsNo Action Indicated (NAI)2211084
Apr 7, 2010Whippany, NJDrugsNo Action Indicated (NAI)2211084
Jun 10, 2009Whippany, NJDrugsNo Action Indicated (NAI)2211084
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.

FacilityLocationInspectionsLatest
FEI 2211084Whippany, NJ13Dec 8, 2025

Halo Pharmaceutical, Inc. D/B/A Cambrex Whippany and the FDA: common questions

Has Halo Pharmaceutical, Inc. D/B/A Cambrex Whippany received an FDA warning letter?

No FDA warning letter addressed to the name "Halo Pharmaceutical, Inc. D/B/A Cambrex Whippany" 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 Halo Pharmaceutical, Inc. D/B/A Cambrex Whippany received an FDA Form 483?

FDA has not published a Form 483 for "Halo Pharmaceutical, Inc. D/B/A Cambrex Whippany" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Halo Pharmaceutical, Inc. D/B/A Cambrex Whippany?

The most recent FDA inspection on file ended Dec 8, 2025 at Whippany, NJ and was classified NAI. FDA has 13 inspections of Halo Pharmaceutical, Inc. D/B/A Cambrex Whippany on file.

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