# FDA WARNING_LETTER - VitalScientific B.V. - March 30, 2017

Source: https://www.globalkeysolutions.net/records/warning_letter/vitalscientific-bv/b72b5b9e-8308-4929-9d79-84077da4145a

> FDA WARNING_LETTER for VitalScientific B.V. on March 30, 2017. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: VitalScientific B.V.
- Inspection Date: 2017-03-30
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On September 20, 2017, the FDA issued a Warning Letter to ELITech Group SAS following an inspection from March 27-30, 2017, at their Spankeren, Netherlands facility. The inspection revealed that their Selectra Pro S, Selectra Pro M, and Viva Junior Analyzer devices were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The devices were also misbranded under 21 U.S.C. § 352(t)(2) for failing to furnish required information under 21 CFR Part 803 (Medical Device Reporting) and 21 CFR Part 806 (Reports of Corrections and Removals).

Key violations include:
1.  **CAPA Procedures (21 CFR 820.100):** Failure to adequately establish and maintain CAPA procedures, including documented instructions for postponing CAPAs and disseminating information. CAPA #239 was improperly postponed and closed.
2.  **Complaint Handling (21 CFR 820.198):** Inadequate procedures for receiving, reviewing, and evaluating complaints, lacking requirements for documenting oral complaints, recording reasons for non-investigation, and comprehensive investigation records. Multiple complaints were not investigated,

## Related Documents

- [483 - 2018-11-05](https://www.globalkeysolutions.net/records/483/vitalscientific-bv/0d0b59ed-3411-4c34-8f62-048ef23de589)

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/alberto-gutierrez/ec16aa77-9dd3-4aff-aae4-1540ea96c5b8)

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

Office: https://www.globalkeysolutions.net/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7