# FDA 483 - Ivers-Lee AG - May 09, 2022

Source: https://www.globalkeysolutions.net/records/483/ivers-lee-ag/68037eb9-1323-4282-a459-84839498dd70

> FDA 483 for Ivers-Lee AG on May 09, 2022. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Ivers-Lee AG
- Inspection Date: 2022-05-09
- Product Type: device
- Office Name: International Compliance Team
- Summary: IVERS-LEE AG, a device manufacturer, was inspected by the FDA from May 9-12, 2022. The inspection revealed significant deficiencies in batch recordkeeping for autoinjector assembly, inadequate validation and qualification of assembly machines, and insufficient frequency and scope of quality audits. These observations indicate a lack of robust quality system controls for the manufacturing of their autoinjector products.

## Related Documents

- [483 - 2023-03-22](https://www.globalkeysolutions.net/records/483/ivers-lee-ag/339de1d3-4ecd-42a3-9603-06f4a29d4d3e)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/ivers-lee-ag/3a8fcee6-5356-430c-a101-fe26decd992a

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321