# FDA 483 - Ivers-Lee AG - March 22, 2023

Source: https://www.globalkeysolutions.net/records/483/ivers-lee-ag/339de1d3-4ecd-42a3-9603-06f4a29d4d3e

> FDA 483 for Ivers-Lee AG on March 22, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ivers-Lee AG
- Inspection Date: 2023-03-22
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Ivers-Lee AG, a drug repacker in Burgdorf, Switzerland, was cited with two observations during an FDA inspection. The observations highlight significant deficiencies in equipment cleaning procedures, including cleaning validation and record keeping, and the accuracy and review of master production and control records. These issues indicate a lack of adequate control over critical manufacturing processes and documentation.

## Related Documents

- [483 - 2022-05-09](https://www.globalkeysolutions.net/records/483/ivers-lee-ag/68037eb9-1323-4282-a459-84839498dd70)

## Related Officers

- [Timothy Ortiz-Colon](https://www.globalkeysolutions.net/people/timothy-ortiz-colon/71a5bdd4-3b56-4a5c-a1c5-378c48a7a225)
- [Investigator](https://www.globalkeysolutions.net/people/lisa-shin/13c87687-fe3d-41a5-8973-42be901a5b0c)
- [Pharmacy Intern/Certified Pharmacy Technician](https://www.globalkeysolutions.net/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)

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

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1