# FDA 483 - Siegfried El Masnou, S.A. - July 11, 2025

Source: https://www.keypedia.com/records/483/siegfried-el-masnou-sa/4130fc9d-43e7-484f-9acb-825c72ccb455

> FDA 483 for Siegfried El Masnou, S.A. on July 11, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Siegfried El Masnou, S.A.
- Inspection Date: 2025-07-11
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Siegfried El Masnou, S.A., a sterile drug product manufacturer in El Masnou, Spain, was cited for significant deficiencies in its aseptic processing, quality control, and record-keeping practices. The inspection revealed inadequate validation of aseptic processes, insufficient cleaning and disinfection protocols, and a deficient environmental monitoring system. Additionally, batch production records were incomplete, and the quality control unit failed to consistently follow its own procedures, including operator re-certification.

## Related Officers

- [Joseph A. Piechocki](https://www.keypedia.com/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)

Company: https://www.keypedia.com/companies/siegfried-el-masnou-sa/7d454af3-32c0-4c5d-b7cb-c11d6cd5096b

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8