Company
United StatesStraumann USA LLC, Andover, MA – FDA Inspections
Inspection records and compliance data for Straumann USA LLC in Andover, Massachusetts. 4 FDA inspections on record, 1 Form 483, last inspected March 04, 2020.
Company Profile
This profile covers Straumann USA LLC based in Andover, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected November 13, 2014. Last inspected March 4, 2020.
Most cited issue areas
- Contamination, mix ups, improper release1 inspection
- Lack of or inadequate procedures1 inspection
- Records of complaint investigation1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 4, 2020 | NAI | Biologics · Vaccines and Allergenic Products | 1122746 |
| July 21, 2017 | VAI | Biologics, Medical Devices & Rad Health · Postmarket Assurance: Devices | 1019048 |
| November 13, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 903595 |
| November 13, 2014 | NAI | Biologics, Medical Devices & Rad Health · Human Cellular, Tissue, and Gene Therapies | 903433 |
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
Straumann USA LLC
FEI Number
1000121052
Address
60 Minuteman Rd, Andover, Massachusetts 01810, United States
Country
United States
ID: 9a27e5b2-2d25-4a71-a1d2-0cfda8b41aa0