FDA Inspection
Lonza Tampa LLCLonza Tampa LLC – FDA Inspection, Jul 14, 2017
Record Details
This FDA Inspection record concerns Lonza Tampa LLC, with an inspection on July 14, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 45aa53cf-ea96-4151-a6fb-734cccd3b240
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1017944
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
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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 |
| January 13, 2017 | VAI | Florida District Office | New Drug Evaluation |
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