Company
GermanyMEDA Manufacturing GmbH, Cologne, Germany – FDA Inspections
Inspection records and compliance data for MEDA Manufacturing GmbH in Cologne. 4 FDA inspections on record, 1 Form 483, last inspected September 07, 2017.
Company Profile
This profile covers MEDA Manufacturing GmbH based in Cologne, Germany.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected January 30, 2009. Last inspected September 7, 2017.
Most cited issue areas
- Control procedures to monitor and validate performance1 inspection
- Measured components for manufacturing1 inspection
- Scientifically sound laboratory controls1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 7, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1024520 |
| September 9, 2016 | NAI | Animal Drugs & Feeds · Monitoring of Marketed Animal Drugs, Feed, and Devices | 990063 |
| November 22, 2013 | NAI | Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices | 872188 |
| January 30, 2009 | NAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 560082 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
MEDA Manufacturing GmbH
FEI Number
3002808393
Address
Neurather Ring 1, Cologne, Germany
Country
Germany
ID: 9dee9c01-de98-4a5e-9ab5-48a473581f49