FDA Inspection
MekoFDA Inspection 1259508 - Meko - January 30, 2025
Record Details
This FDA Inspection record concerns Meko, with an inspection on January 30, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 555646de-8b89-4f35-9b32-d8d54ac3cee3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1259508
- FDA center
- Medical Devices & Rad Health
- Project area
- Product Evaluation: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.22Quality audits - auditor independence
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Meko
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 14, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| February 21, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| 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 1256728 - 2024-11-14
- FDA Inspection 1080539 - 2019-02-21
- FDA Inspection 996283 - 2017-01-06
- FDA Inspection 961490 - 2016-02-11
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