Form FDA 483 · Issued 2026-04-16
Lonza Biologics, Inc. — FDA Form 483 Analysis
FEI: 3001451441 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Drug Manufacturer) · Lead Investigator: Jonathan A. Vance
FDA Form 483 issued to Lonza Biologics, Inc. (FEI 3001451441) on 2026-04-16 following an inspection of its drug manufacturer operations in New Hampshire. The report documents 5 inspection observations centered on Cleaning Validation, Sanitation Logs & Pest Control, Electronic Record Data Integrity (21 CFR Part 11) & Retention.
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 21 CFR 211.42(a)
Cleaning Validation, Sanitation Logs & Pest Control
FIRST-TIME OBSERVATION
Buildings of Suitable Size, Construction, Location
Inspector Observation Language: "Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable [size] [construction] [location] to facilitate cleaning, maintenance, and proper operations. Specifically, observed during inspection of Lonza Biologics, Inc. on 2026-04-16."
Plain-English Meaning: Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
Standard CAPA Remediation Path: Implement lot-linked equipment cleaning verification logs with QA sign-off before line clearance, ATP/allergen swabbing after shared-line runs, and weekly documented pest-control inspections.
Observation #2 · 21 CFR 314.80(b)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Failure to develop written procedures
Inspector Observation Language: "Written procedures have not been developed for the [surveillance] [receipt] [evaluation] [reporting to FDA] of post marketing adverse drug experiences. Specifically, observed during inspection of Lonza Biologics, Inc. on 2026-04-16."
Plain-English Meaning: Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
Standard CAPA Remediation Path: Enforce unique user credentials, immutable audit trails on analytical instruments, controlled form issuance numbers, and 2-year post-expiration record retention.
Observation #3 · 21 CFR 211.182
Cleaning Validation, Sanitation Logs & Pest Control
FIRST-TIME OBSERVATION
Written records kept in individual logs
Inspector Observation Language: "Written records of major equipment [cleaning] [maintenance] [use] are not included in individual equipment logs. Specifically, observed during inspection of Lonza Biologics, Inc. on 2026-04-16."
Plain-English Meaning: Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
Standard CAPA Remediation Path: Implement lot-linked equipment cleaning verification logs with QA sign-off before line clearance, ATP/allergen swabbing after shared-line runs, and weekly documented pest-control inspections.
Observation #4 · 21 CFR 211.125(a)
Label Control, Undeclared Allergens & Structure/Function Claims
REPEAT CITATION AT FACILITY
Strict control not exercised over labeling issued
Inspector Observation Language: "Strict control is not exercised over labeling issued for use in drug product labeling operations. Specifically, observed during inspection of Lonza Biologics, Inc. on 2026-04-16."
Plain-English Meaning: Undeclared major food allergens (milk, soy, wheat, tree nuts, peanuts, egg, sesame), label mix-ups at the packaging line, or unauthorized disease treatment claims.
Standard CAPA Remediation Path: Implement 100% barcode/vision verification on packaging lines, strict allergen matrix segregation, and regulatory review removing disease endpoints from supplement/cosmetic copy.
Observation #5 · 21 CFR 211.46(b)
Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems
FIRST-TIME OBSERVATION
Equipment for Environmental Control
Inspector Observation Language: "Equipment for adequate control over [air pressure] [micro-organisms] [dust] [humidity] [temperature] is not provided when appropriate for the manufacture, processing, packing or holding of a drug product. Specifically, observed during inspection of Lonza Biologics, Inc. on 2026-04-16."
Plain-English Meaning: Scales, thermometers, pH meters, autoclaves, or purified water systems lacking current NIST-traceable calibration or process validation.
Standard CAPA Remediation Path: Tag all critical measuring instruments with calibration due dates, lock out overdue devices, and perform weekly TOC/conductivity/bioburden testing on purified water loops.