# FDA 483 - HP Halden Pharma AS - May 10, 2023

Source: https://www.globalkeysolutions.net/records/483/hp-halden-pharma-as/6fa4a79b-8d45-42e4-8815-d40ba3827ba2

> FDA 483 for HP Halden Pharma AS on May 10, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: HP Halden Pharma AS
- Inspection Date: 2023-05-10
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Fresenius Kabi Norge As, a drug manufacturer, revealed significant quality system deficiencies. The firm failed to thoroughly investigate discrepancies, maintain adequate production and process controls, and prevent contamination during material handling and storage. Additionally, drug products were found to be stored outside their specified temperature ranges.

## Related Documents

- [483 - 2019-09-03](https://www.globalkeysolutions.net/records/483/hp-halden-pharma-as/0b8630dc-a7eb-4b55-84fd-80f62b916fda)
- [483 - 2023-05-10](https://www.globalkeysolutions.net/records/483/hp-halden-pharma-as/6b218f6c-855c-482a-8ce3-1749e25b12ea)

## Related Officers

- [GDUFA Pharmaceutical Investigator](https://www.globalkeysolutions.net/people/kevin-p-regan/b870e1f2-017c-44ab-bc99-1ca99b474a04)
- [Consumer Safety Officer (Drug Specialist)](https://www.globalkeysolutions.net/people/alan-p-kurtzberg/36ee316e-6d19-44b2-a131-fc254ada4f41)

Company: https://www.globalkeysolutions.net/companies/hp-halden-pharma-as/2c8c6d51-da3a-476a-9abd-da411b527728

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