FDA Inspection
MekoFDA Inspection 1080539 - Meko - February 21, 2019
Record Details
This FDA Inspection record concerns Meko, with an inspection on February 21, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Meko
- Inspection Date
- February 21, 2019
- Product Type
- Devices
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ID · ac123f33-591a-47df-9404-80d43b4eedf2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1080539
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.90(a)Nonconforming product control
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Meko
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 30, 2025 | VAI | Office of Inspections and Investigations | Product Evaluation: Medical Devices |
| November 14, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| January 6, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 11, 2016 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Meko
- FDA Inspection 1259508 - 2025-01-30
- FDA Inspection 1256728 - 2024-11-14
- FDA Inspection 996283 - 2017-01-06
- FDA Inspection 961490 - 2016-02-11
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