Company
GermanyPenCef Pharma GmbH, Berlin, Germany – FDA Inspections
Inspection records and compliance data for PenCef Pharma GmbH in Berlin. 2 FDA inspections on record, 2 Form 483s, last inspected September 27, 2023.
Company Profile
This profile covers PenCef Pharma GmbH based in Berlin, Germany.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected May 12, 2017. Last inspected September 27, 2023.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Component addition checked by 2nd person1 inspection
- Computer control of master formula records1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 27, 2023 | VAI | Animal Drugs & Feeds · Pre-Approval Eval. of Animal Drugs and Food Additives | 1219959 |
| May 12, 2017 | VAI | Animal Drugs & Feeds · Pre-Approval Eval. of Animal Drugs and Food Additives | 1013171 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
PenCef Pharma GmbH
FEI Number
3008654273
Address
Breitenbachstr. 13, Berlin, Germany
Country
Germany
ID: 0c06d1f1-9da6-4d1d-9abc-19d5d71e6edf