# FDA 483 - NerPharMa S.r.l. - June 27, 2025

Source: https://www.keypedia.com/records/483/nerpharma-srl/8fe3528c-de7e-4811-9cbd-81f9a82addb1

> FDA 483 for NerPharMa S.r.l. on June 27, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: NerPharMa S.r.l.
- Inspection Date: 2025-06-27
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: The FDA inspected NerPharMa S.r.l. in Nerviano, Milan, Italy, a drug manufacturer, and identified significant deficiencies. The observations primarily concern inadequate aseptic processing controls, environmental monitoring, cleaning procedures, and a lack of robust investigation and quality control systems. These issues indicate a failure to ensure the sterility, purity, and quality of drug products.

## Related Documents

- [EIR - 2023-02-20](https://www.keypedia.com/records/eir/nerpharma-srl/cd1e6bfd-e9c7-4007-88cb-e9f3d5234506)
- [483 - 2024-06-19](https://www.keypedia.com/records/483/nerpharma-srl/665c1740-e571-418a-a5d0-7f768a20b6ee)
- [483 - 2024-06-19](https://www.keypedia.com/records/483/nerpharma-srl/c4a3d96a-3ef1-4a8c-a490-a578cc3de3dc)
- [483 - 2025-06-27](https://www.keypedia.com/records/483/nerpharma-srl/85ea03e1-6a3e-4df7-9f00-3181acb33551)
- [483 - 2025-06-27](https://www.keypedia.com/records/483/nerpharma-srl/b59387cb-4c26-4bc0-b487-89c0c17094f7)

## Related Officers

- [Eileen A. Liu](https://www.keypedia.com/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)
- [Consumer Safety Officer](https://www.keypedia.com/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)

Company: https://www.keypedia.com/companies/nerpharma-srl/12f11f8a-e70e-4598-807c-a1571bab0391

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