FDA Inspection
Lonza Tampa LLCLonza Tampa LLC – FDA Inspection, Jan 13, 2017
Record Details
This FDA Inspection record concerns Lonza Tampa LLC, with an inspection on January 13, 2017, issued by the Florida District Office, covering human drugs.
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ID · 1fd078e0-c2ae-4ea2-a216-d32eeb37fa03
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 997589
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Lonza Tampa LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2025 | VAI | Florida District Office | Drug Quality Assurance |
| September 29, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 1, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 20, 2018 | VAI | Center for Drug Evaluation and Research | New Drug Evaluation |
| July 14, 2017 | OAI | Center for Drug Evaluation and Research | New Drug Evaluation |
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