# FDA 483 - Meko - February 21, 2019

Source: https://www.globalkeysolutions.net/records/483/meko/64f738d5-3264-4943-bad7-73d76c4e35ef

> FDA 483 for Meko on February 21, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Meko
- Inspection Date: 2019-02-21
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Meko, a medical device manufacturer in Sarstedt, Germany, revealed significant quality system deficiencies. The firm failed to adequately control nonconforming products and did not follow its own procedures for initiating nonconformance reports. Additionally, quality audits were conducted by personnel with direct responsibility for the audited areas, compromising auditor independence.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/roy-baby/69a18ef5-167c-41eb-a57e-3d138a0820c2)

Company: https://www.globalkeysolutions.net/companies/meko/ee585fb9-ab78-4b2d-8182-cb6fc56da68e

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd