FDA Inspection
Lonza Biologics PlcLonza Biologics Plc – FDA Inspection, Jun 24, 2016
Record Details
This FDA Inspection record concerns Lonza Biologics Plc, with an inspection on June 24, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Lonza Biologics Plc
- Inspection Date
- June 24, 2016
- Product Type
- Drugs
View Company Profile
ID · 4cdfb86e-483c-4c1c-9222-982dd09ae126
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 978909
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Lonza Biologics Plc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 13, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 28, 2018 | Not classified | Office of Inspections and Investigations | |
| September 5, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 31, 2017 | Not classified | Office of Inspections and Investigations | |
| September 24, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Lonza Biologics Plc
- FDA Inspection 1202907 - 2022-10-13
- FDA Inspection 1070651 - 2018-09-28
- FDA Inspection 1097017 - 2018-09-05
- FDA Inspection 1021064 - 2017-03-31
- FDA Inspection 801062 - 2012-09-24
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