FDA Inspection
Lonza Biologics, Inc.Lonza Biologics, Inc. – FDA Inspection, Apr 16, 2026
Record Details
This FDA Inspection record concerns Lonza Biologics, Inc., with an inspection on April 16, 2026, issued by the New England District Office, covering biologics.
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ID · 5bbfa47f-509d-40b8-bed0-301a8269c65e
Inspection Facts
- Inspection number
- 1312718
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.142Written warehousing procedures established/followed
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Other FDA inspections of Lonza Biologics, Inc.
12| Date | Classification | Office | Project area |
|---|---|---|---|
| February 6, 2026 | Not classified | New England District Office | |
| June 6, 2025 | Not classified | New England District Office | |
| July 12, 2024 | Not classified | New England District Office | |
| March 7, 2024 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| July 21, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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