Lonza Biologics, Inc.
Registered Address: New Hampshire, USA (USA)
5 Questions to Ask Lonza Biologics, Inc. Before Signing a Manufacturing Contract
Bring these exact questions to your discovery call with their QA Director or account rep before wiring a production deposit:
- Q1: On 2026-04-16, FDA cited 21 CFR 211.42(a) (Cleaning Validation, Sanitation Logs & Pest Control). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
- Q2: On 2026-04-16, FDA cited 21 CFR 314.80(b) (Electronic Record Data Integrity (21 CFR Part 11) & Retention). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
- Q3: On 2026-04-16, FDA cited 21 CFR 211.182 (Cleaning Validation, Sanitation Logs & Pest Control). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
- Q4: Do you perform 100% FTIR/HPLC identity testing on incoming active ingredients in-house (21 CFR 111.75(a)(1)), or do you rely on vendor COAs?
- Q5: Will you sign our Quality Agreement Rider requiring 24-hour notification if an FDA investigator issues a Form 482 or Form 483 at FEI 3001451441?
Cross-Database Regulatory & Inspection Timeline
Unified chronological history across FDA ORA Inspections, Form 483s, Warning Letters, Enforcement Recalls, and OASIS Import Refusals.
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.
- 21 CFR 211.42(a) (Cleaning Validation, Sanitation Logs & Pest Control): Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
- 21 CFR 314.80(b) (Electronic Record Data Integrity (21 CFR Part 11) & Retention): Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
- 21 CFR 211.182 (Cleaning Validation, Sanitation Logs & Pest Control): Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
- 21 CFR 211.125(a) (Label Control, Undeclared Allergens & Structure/Function Claims): Undeclared major food allergens (milk, soy, wheat, tree nuts, peanuts, egg, sesame), label mix-ups at the packaging line, or unauthorized disease treatment claims. REPEAT OBSERVATION
- 21 CFR 211.46(b) (Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems): Scales, thermometers, pH meters, autoclaves, or purified water systems lacking current NIST-traceable calibration or process validation.
Manufacturer Right-of-Reply & Free Match Correction
GUARDRAIL PROTECTEDTo ensure fairness and accuracy, facility owners may submit verified Form 483 closeout evidence, CAPA completion statements, or entity-resolution corrections free of charge. Sponsorship never alters an FDA Record Index score.
6-Subsystem cGMP Radar Breakdown
Sub-scores mapped across FDA's six core inspection subsystems.
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Score Provenance Receipts
Every point in this facility's FDA Record Index (60/100) is backed by a linked government record (36-month half-life decay).
| Event | Date | Weight | Receipt |
|---|---|---|---|
| Inspection Outcome (VAI) | 2026-04-16 | -8.8 pts | INSP-483-3001451441-20260416 ↗ |
| Form 483 (5 observations, 1 repeat) | 2026-04-16 | -15.9 pts | 483-3001451441-20260416 ↗ |
| Import Refusal (ADULTERATED DIETARY SUPPLEMENT — CGMP) | 2026-09-19 | -7.8 pts | OASIS-2026-88117 ↗ |