Company
GermanyMeko - Inspection Records
Inspection records and compliance data for Meko in Sarstedt. 5 FDA inspections on record (1 OAI), 1 Form 483, last inspected January 30, 2025.
Company Profile
This profile covers Meko based in Sarstedt, Germany.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 2
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected February 11, 2016. Last inspected January 30, 2025.
Most cited issue areas
- Quality audits - auditor independence2 inspections
- Nonconforming product control1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 30, 2025 | VAI | Medical Devices & Rad Health · Product Evaluation: Medical Devices | 1259508 |
| November 14, 2024 | NAI | Human Drugs · Bioresearch Monitoring | 1256728 |
| February 21, 2019 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1080539 |
| January 6, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 996283 |
| February 11, 2016 | OAI | Medical Devices & Rad Health · Compliance: Devices | 961490 |
FDA documents
Form 483s (1)
Company Information
Name
Meko
FEI Number
3009937642
Address
Im Kirchenfelde 12-14, Sarstedt, Germany
Country
Germany
ID: ee585fb9-ab78-4b2d-8182-cb6fc56da68e