# FDA 483 - Theo Manufacturing BV - May 22, 2019

Source: https://www.keypedia.com/records/483/theo-manufacturing-bv/5bf20eaa-9a12-4318-8a48-bc8420285ba8

> FDA 483 for Theo Manufacturing BV on May 22, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Theo Manufacturing BV
- Inspection Date: 2019-05-22
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Thea Manufacturing BV in Maastricht, Netherlands, a manufacturer of L-Mesitran products, revealed significant deficiencies in their quality system. Observations included inadequate supplier control procedures, a lack of independent auditors for internal quality audits, and multiple issues related to the documentation of design controls. Specifically, design review results, design verification results, and design outputs were not adequately documented in the design history files for their products.

## Related Officers

- [Dedicated Device Cadre](https://www.keypedia.com/people/dedicated-device-cadre/693932db-dd86-453f-9b51-a63444b07281)
- [investigator](https://www.keypedia.com/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.keypedia.com/companies/theo-manufacturing-bv/6d060981-3de3-47d9-be41-ff5afa47cb0c

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