Lonza Biologics, Inc. — FDA Facility Profile

FEI 3001451441

Lonza Biologics, Inc. is an FDA-registered facility (FEI 3001451441) located in Portsmouth, NH, US. Registered operations: ANALYSIS; API MANUFACTURE. RegDataLab tracks 9 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Feb 6, 2026: Voluntary Action Indicated (VAI)
Inspections on record
9 (7 VAI, 2 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
Form 483 and inspection documents
2 in FDA's reading room

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
Feb 6, 2026Voluntary Action Indicated (VAI)No citations listed
Mar 7, 2024No Action Indicated (NAI)No citations listed
Jul 21, 2023Voluntary Action Indicated (VAI)No citations listed
Sep 21, 2017No Action Indicated (NAI)No citations listed
Aug 26, 2016Voluntary Action Indicated (VAI)No citations listed
Feb 10, 2015Voluntary Action Indicated (VAI)No citations listed
Sep 30, 2013Voluntary Action Indicated (VAI)No citations listed
Apr 21, 2010Voluntary Action Indicated (VAI)No citations listed
Sep 3, 2009Voluntary Action Indicated (VAI)No citations listed

Form 483s and inspection documents

Facility details

Company
Lonza Biologics, Inc.
Location
Portsmouth, NH (US)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; API MANUFACTURE
Source
decrs

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