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•United States

Lonza Biologics, Inc., Portsmouth, NH – FDA Inspections

Inspection records and compliance data for Lonza Biologics, Inc. in Portsmouth, New Hampshire. 13 FDA inspections on record, 5 Form 483s, last inspected April 16, 2026.

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Company Profile

This profile covers Lonza Biologics, Inc. based in Portsmouth, New Hampshire, United States.

FDA Inspection History

FDA inspections
13
OAI
0
VAI
6
NAI
2
Unclassified
5
Form 483s
5
Warning letters
0

First inspected September 3, 2009. Last inspected April 16, 2026.

Most cited issue areas

  • Absence of Written Procedures1 inspection
  • Procedures for sterile drug products1 inspection
  • Written warehousing procedures established/followed1 inspection

FDA inspections (13)

DateResultFDA center(s)Insp. #
April 16, 2026Not classifiedBiologics · Blood and Blood Products1312718
February 6, 2026Not classifiedHuman Drugs1304046
June 6, 2025Not classifiedBiologics1269735
July 12, 2024Not classifiedHuman Drugs1246345
March 7, 2024NAIBiologics · Vaccines and Allergenic Products1232144
July 21, 2023VAIHuman Drugs · Drug Quality Assurance1210690
February 7, 2018Not classifiedHuman Drugs1040839
September 21, 2017NAIHuman Drugs · Drug Quality Assurance1028939
August 26, 2016VAIHuman Drugs · Drug Quality Assurance988692
February 10, 2015VAIHuman Drugs · Drug Quality Assurance914920
September 30, 2013VAIHuman Drugs · Drug Quality Assurance850896
April 21, 2010VAIHuman Drugs · Drug Quality Assurance659362
September 3, 2009VAIHuman Drugs · Drug Quality Assurance611071
FDA documents

Form 483s (7)

  • Form 483s · April 16, 2026
  • Form 483s · February 6, 2026
  • Form 483s · June 6, 2025
  • Form 483s · March 7, 2024
  • Form 483s · July 21, 2023
  • Form 483s · October 22, 2021
  • Form 483s · November 3, 2020

EIRs (1)

  • EIRs · November 3, 2020
People (4)
Wayne E. Seifert
Person
Jacek Cieslak
Person
Pete Amin
Person
Obinna R. Echeozo
Person
Related Companies (10)

Companies with similar regulatory profiles, compliance history, and operations.

Cytovance Biologics Inc.
Biogen MA Inc.
Boehringer Ingelheim RCV GmbH & Co KG
Bachem Americas, Inc.
Chinese Peptide Company
DSM Nutritional Products (UK) Ltd
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC
Cheng Fong Chemical Co., Ltd. Dayuan Factory
Apitoria Pharma Private Limited
PCAS Finland Oy
Company Information

Name

Lonza Biologics, Inc.

FEI Number

3001451441

Address

101 International Dr, Portsmouth, New Hampshire 03801, United States

Country

United States

ID: f9882ce5-d92a-4c88-916e-8f4e6d1f2aff

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Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
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