Company
GermanyRotop Pharmaka GmbH, Dresden, Germany – FDA Inspections
Inspection records and compliance data for Rotop Pharmaka GmbH in Dresden. 2 FDA inspections on record, 1 Form 483, last inspected July 02, 2021.
Company Profile
This profile covers Rotop Pharmaka GmbH based in Dresden, Germany.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected December 7, 2018. Last inspected July 2, 2021.
Most cited issue areas
- Annual visual exams of drug products1 inspection
- GMP Training Frequency1 inspection
- Second person sign off1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 2, 2021 | VAI | Human Drugs · Drug Quality Assurance | 1255703 |
| December 7, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1073907 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Rotop Pharmaka GmbH
FEI Number
3009075542
Address
Bautzner Landstr. 400, Dresden, Germany
Country
Germany
ID: 2e70dc22-0e67-419c-9336-09aac288a049