Company
United StatesWassenburg Medical, Inc., Ivyland, PA – FDA Inspections
Inspection records and compliance data for Wassenburg Medical, Inc. in Ivyland, Pennsylvania. 7 FDA inspections on record (3 OAI), last inspected October 19, 2018.
Company Profile
This profile covers Wassenburg Medical, Inc. based in Ivyland, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 3
- VAI
- 2
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected May 26, 2010. Last inspected October 19, 2018.
Most cited issue areas
- Complaints1 inspection
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation - documentation1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 19, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1077765 |
| April 28, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1010565 |
| April 24, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 923746 |
| November 19, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 904108 |
| November 8, 2012 | OAI | Medical Devices & Rad Health · Compliance: Devices | 807881 |
| January 26, 2012 | OAI | Medical Devices & Rad Health · Compliance: Devices | 765157 |
| May 26, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 663752 |
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
Wassenburg Medical, Inc.
FEI Number
2523209
Address
144 Railroad Dr, Ivyland, Pennsylvania 18974, United States
Country
United States
ID: 56897acb-a3d9-4837-bc80-98125e8e9b86