# FDA 483 - ELOS MEDTECH PINOL A/S - February 07, 2019

Source: https://www.globalkeysolutions.net/records/483/elos-medtech-pinol-as/daf2b7f9-2211-4c9d-80d0-f3438f2bac35

> FDA 483 for ELOS MEDTECH PINOL A/S on February 07, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ELOS MEDTECH PINOL A/S
- Inspection Date: 2019-02-07
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of ELOS MEDTECH PINOL A/S in Gorlose, Denmark, from February 4-7, 2019, revealed two significant observations. The firm's corrective and preventive action (CAPA) procedures were found to be inadequate, specifically concerning the dissemination of information related to quality problems. Additionally, records for acceptable contractors were not properly established, as the approved supplier list inaccurately classified a production equipment maintenance provider.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.globalkeysolutions.net/companies/elos-medtech-pinol-as/78979286-b8b4-47cc-80d1-7ff458c794b3

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