# FDA 483 - Delpharm Dijon - May 31, 2024

Source: https://www.keypedia.com/records/483/delpharm-dijon/bd526063-dc9f-4688-9ee5-26a0d5bb1f98

> FDA 483 for Delpharm Dijon on May 31, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Delpharm Dijon
- Inspection Date: 2024-05-31
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Delpharm Dijon, a sterile drug manufacturer in Quetigny, France, revealed significant deficiencies in their manufacturing processes. Observations included inadequate master production and control records lacking theoretical yield and percentage calculations, and a failure to establish appropriate time limits for production phases to ensure drug product quality.

## Related Documents

- [483 - 2024-05-31](https://www.keypedia.com/records/483/delpharm-dijon/232d08fe-df7f-417c-8505-5ad33aa108d4)

## Related Officers

- [Investigator](https://www.keypedia.com/people/jolanna-a-norton/5501fea4-4bfd-434c-b2aa-fcf94444f684)
- [Liya Tang](https://www.keypedia.com/people/liya-tang/f4103ebd-2bdd-48c7-b1c1-07b5421e8b64)

Company: https://www.keypedia.com/companies/delpharm-dijon/8f766752-64b7-4166-b421-2fbe7803560d

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