# FDA 483 - Replimune Limited - Unknown Date

Source: https://www.keypedia.com/records/483/replimune-limited/f8ae45c0-c6a4-4755-913a-0f34ef9ee072

> FDA 483 for Replimune Limited on Unknown Date. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Replimune Limited
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: Replimune Limited, a manufacturer and control laboratory in Oxford, Abingdon, United Kingdom, was cited for two observations during an FDA inspection. The inspection revealed deficiencies in method validation and calibration procedures, as well as inadequate justification for retesting analytical samples following out-of-specification results without identifying a root cause.

## Related Officers

- [investigator](https://www.keypedia.com/people/wei-wang/943039ac-3917-4d32-9f58-1886c56aecdd)
- [Joshua Kuten](https://www.keypedia.com/people/joshua-kuten/1e6dce63-070b-4c13-8cc1-23a0b834d81e)

Company: https://www.keypedia.com/companies/replimune-limited/23089ec0-6a36-4778-8a07-ab1e897b6e47

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4