Company
GermanyDynamit Nobel GmbH Explosivstoff- und Systemtechnik, Leverkusen, Germany – FDA Inspections
Inspection records and compliance data for Dynamit Nobel GmbH Explosivstoff- und Systemtechnik in Leverkusen. 5 FDA inspections on record, 1 Form 483, last inspected September 01, 2023.
Company Profile
This profile covers Dynamit Nobel GmbH Explosivstoff- und Systemtechnik based in Leverkusen, Germany.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected May 22, 2009. Last inspected September 1, 2023.
Most cited issue areas
- Investigations of discrepancies, failures1 inspection
- Procedures not in writing, fully followed1 inspection
- Written procedures fail to include1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 1, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1272891 |
| December 7, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1073746 |
| May 6, 2016 | NAI | Human Drugs · Drug Quality Assurance | 970975 |
| July 18, 2013 | VAI | Human Drugs · Drug Quality Assurance | 845075 |
| May 22, 2009 | NAI | Human Drugs · Drug Quality Assurance | 585821 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Dynamit Nobel GmbH Explosivstoff- und Systemtechnik
FEI Number
1379
Address
Kalkstr. 218, Leverkusen, Germany
Country
Germany
ID: ca67cc94-7471-4b87-b76c-a85784596b96