FDA Inspection
Lonza Bend IncLonza Bend Inc – FDA Inspection, Jun 3, 2016
Record Details
This FDA Inspection record concerns Lonza Bend Inc, with an inspection on June 3, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Lonza Bend Inc
- Inspection Date
- June 3, 2016
- Product Type
- Drugs
View Company Profile
ID · 1ff195ed-dca3-457a-81b6-bf7491e00f00
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 985218
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.22(c)Approve or reject procedures or specs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Lonza Bend Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 5, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 27, 2018 | Not classified | Seattle District Office | New Drug Evaluation |
| June 30, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Lonza Bend Inc
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.