# FDA 483 - Chiesi Farmaceutici S.p.A. - March 28, 2025

Source: https://www.keypedia.com/records/483/chiesi-farmaceutici-spa/e5aac9bd-5951-4844-b819-6e4761d9a295

> FDA 483 for Chiesi Farmaceutici S.p.A. on March 28, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chiesi Farmaceutici S.p.A.
- Inspection Date: 2025-03-28
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Chiesi Farmaceutici S.p.A. in Parma, Italy, revealed significant deficiencies in quality control. Observations included inadequate visual inspection procedures and operator qualification, insufficient acceptance criteria for biological indicators in sterilization, and compromised drug product system integrity due to observed droplets. These issues collectively point to a heightened risk of product quality and sterility concerns.

## Related Documents

- [483 - 2023-04-11](https://www.keypedia.com/records/483/chiesi-farmaceutici-spa/633aba95-2ec2-4e85-9f1a-788baa143988)

## Related Officers

- [Emine GuvenMaiorov](https://www.keypedia.com/people/emine-guvenmaiorov/00186865-3b56-4115-8c4b-cea8072a314b)
- [Maria G. Gutierrez-Hoffman](https://www.keypedia.com/people/maria-g-gutierrez-hoffman/4a740635-49a6-451b-b002-416a00eb7d1f)
- [Madushini N. Dharmasena](https://www.keypedia.com/people/madushini-n-dharmasena/c6dbff15-4c5f-475e-8ec1-581d8e65f76c)

Company: https://www.keypedia.com/companies/chiesi-farmaceutici-spa/c5c5e25e-4e01-482a-b5b3-7a7b11458a67

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