Company
United StatesCovis Pharma GmBH, Waltham, MA – FDA Inspections
Inspection records and compliance data for Covis Pharma GmBH in Waltham, Massachusetts. 8 FDA inspections on record, last inspected September 19, 2024.
Company Profile
This profile covers Covis Pharma GmBH based in Waltham, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 3
- NAI
- 5
- Form 483s
- 0
- Warning letters
- 0
First inspected August 3, 2011. Last inspected September 19, 2024.
Most cited issue areas
- Failure to develop written procedures1 inspection
- Failure to investigate serious, unexpected events1 inspection
- Failure to meet specifications1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 19, 2024 | NAI | Human Drugs · Bioresearch Monitoring | 1250807 |
| April 5, 2019 | NAI | Human Drugs · Bioresearch Monitoring | 1087302 |
| October 22, 2018 | NAI | Human Drugs · Bioresearch Monitoring | 1071326 |
| July 15, 2016 | VAI | Human Drugs · Bioresearch Monitoring | 981007 |
| July 28, 2014 | NAI | Human Drugs · Bioresearch Monitoring | 892953 |
| May 21, 2014 | VAI | Human Drugs · Drug Quality Assurance | 878312 |
| February 7, 2013 | NAI | Human Drugs · Bioresearch Monitoring | 819091 |
| August 3, 2011 | VAI | Human Drugs · Bioresearch Monitoring | 739999 |
FDA documents
People (5)
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Company Information
Name
Covis Pharma GmBH
FEI Number
3008152278
Address
1100 Winter St, Waltham, Massachusetts 02451, United States
Country
United States
ID: d1616a5d-a379-4021-b5aa-ef8f369c9a92