# FDA 483 - Progenics Pharmaceuticals, Inc. - March 20, 2020

Source: https://www.keypedia.com/records/483/progenics-pharmaceuticals-inc/eb8e124b-f3f1-4ee5-a89d-e78d536da49a

> FDA 483 for Progenics Pharmaceuticals, Inc. on March 20, 2020. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Progenics Pharmaceuticals, Inc.
- Inspection Date: 2020-03-20
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Progenics Pharmaceuticals, Inc. received a Form 483 citing multiple significant deficiencies in its manufacturing operations for AZEDRA (Iobenguane I 131) Injection. The inspection revealed failures in thoroughly investigating out-of-specification results, maintaining adequate quality control unit procedures, and completing annual product reviews. Additional concerns included inadequate facility space, poor material segregation, insufficient computer system controls, and a deficient environmental monitoring program for sterile drug products.

## Related Officers

- [Yvins Dezan](https://www.keypedia.com/people/yvins-dezan/e9fd12e6-c090-4eb6-bc78-8b80e8a90946)

Company: https://www.keypedia.com/companies/progenics-pharmaceuticals-inc/c0c3dc44-085b-44e7-ba3e-8a222a4898f1

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248