Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3001451441.
Observations10
Issue DateJune 06, 2025
StatusWarning Letter Issued
Establishment TypeDrug Product Manufacturer
Related Inspections9
Establishment Details
Firm
Lonza Portsmouth, Inc.
Location
New Hampshire, United States
FEI Number
3001451441
Establishment Type
Drug Product Manufacturer
Product Type
Drugs
Issue Date
June 06, 2025
Country
United States
Inspection History, 2009 to 2026
NAI1
VAI8
NAI means No Action Indicated. VAI means Voluntary Action Indicated.