# FDA 483 - VitalScientific B.V. - November 05, 2018

Source: https://www.globalkeysolutions.net/records/483/vitalscientific-bv/0d0b59ed-3411-4c34-8f62-048ef23de589

> FDA 483 for VitalScientific B.V. on November 05, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: VitalScientific B.V.
- Inspection Date: 2018-11-05
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: During an inspection of ELITechGroup B.V. in Spankeren, Netherlands, the FDA observed two issues related to the firm's device manufacturing processes. The observations highlight inadequate procedures for accepting incoming products and deficiencies in establishing training and identifying training needs for employees. These findings indicate a need for improved quality system controls within the facility.

## Related Documents

- [WARNING_LETTER - 2017-03-30](https://www.globalkeysolutions.net/records/warning_letter/vitalscientific-bv/b72b5b9e-8308-4929-9d79-84077da4145a)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)

Company: https://www.globalkeysolutions.net/companies/vitalscientific-bv/a57f6e1d-38db-44e4-8643-e6a880059238

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