# FDA 483 - Argon Medical Productions & Vertrieb Gesellschaft MBH & CO - Unknown Date

Source: https://www.keypedia.com/records/483/argon-medical-productions-vertrieb-gesellschaft-mbh-co/42d93f36-4c0b-4df5-bbe2-c925b7377240

> FDA 483 for Argon Medical Productions & Vertrieb Gesellschaft MBH & CO on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Argon Medical Productions & Vertrieb Gesellschaft MBH & CO
- Product Type: device
- Office Name: Foreign - CBER (Bioresearch Monitoring)
- Summary: Argon Medical Productions & Vertriebs Gesellschaft MBH & Co, a device manufacturer in Bingen Am-Rhein, Germany, was cited for significant deficiencies in its post-market surveillance and quality system. Observations included a lack of written Medical Device Reporting (MDR) procedures, failure to submit an MDR report for serious injuries related to dental implant failures, and issues with Unique Device Identifier (UDI) labeling and database registration. Additionally, the firm failed to investigate complaints involving device failures.

## Related Documents

- [WARNING_LETTER - 2024-07-31](https://www.keypedia.com/records/warning_letter/argon-medical-productions-vertrieb-gesellschaft-mbh-co/4542dcec-c462-4a9f-b948-a1fa39b25489)

## Related Officers

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

Company: https://www.keypedia.com/companies/argon-medical-productions-vertrieb-gesellschaft-mbh-co/7af03e02-d6b2-4ff5-ac98-0bd69e55810c

Office: https://www.keypedia.com/offices/foreign-cber-bioresearch-monitoring/f1660531-9111-4f36-bf5d-b28bf0f3b54e