Company
GermanyAlber GmbH, Albstadt, Germany – FDA Inspections
Inspection records and compliance data for Alber GmbH in Albstadt. 4 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected December 15, 2022.
Company Profile
This profile covers Alber GmbH based in Albstadt, Germany.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 1
First inspected August 28, 2014. Last inspected December 15, 2022.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 15, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1194458 |
| April 12, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1053177 |
| May 11, 2017 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1015469 |
| August 28, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 895240 |
FDA documents
Warning Letters (1)
People (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Alber GmbH
FEI Number
3004730072
Address
Vor Dem Weisen Stein 14, Albstadt, Germany
Country
Germany
ID: f9a38543-93af-448e-98bf-82c1ced98142