# FDA 483 - Sanofi S.r.l. - May 22, 2023

Source: https://www.keypedia.com/records/483/sanofi-srl/2279210a-e1bd-440f-986a-4fcd7039ee8d

> FDA 483 for Sanofi S.r.l. on May 22, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sanofi S.r.l.
- Inspection Date: 2023-05-22
- Product Type: Drugs
- Office Name: Division of Biotechnology Manufacturing
- Summary: An FDA inspection conducted at Sanofi S.p.A"s Anagni, Italy, facility from May 12 to May 22, 2023, revealed significant observations concerning the manufacturing of sterile drug products. The inspection highlighted a failure to establish and consistently follow procedures designed to prevent microbiological contamination. Specific issues included the non-aseptic setup of sterilized stopper bowls, exposure of sterile components to non-sterile air, and the use of non-sterile gloves during critical aseptic connections, often blocking first air on sterile parts. Operators were also observed touching sterile tubing ends with gloves during installation, compromising product sterility. Furthermore, vials destined for rejection were co-mingled with acceptable vials without a formal risk assessment for potential cross-contamination. The sterility of sterilized equipment was not consistently maintained due to improper handling. A second key observation noted that aseptic process simulations, crucial for validating sterile manufacturing, did not fully represent actual drug product production. The firm exclusively used dedicated, "like-for-like" equipment for media fills rather than the equipment utilized in routine production. These observations indicate deviations from Good Manufacturing Practices (GMP) essential for sterile product safety. Sanofi S.p.A is required to implement thorough corrective and preventive actions to rectify these deficiencies and ensure robust aseptic processing and accurate process validation.

## Related Documents

- [483 - 2023-02-02](https://www.keypedia.com/records/483/sanofi-srl/4b220987-179f-49af-987e-cfdcfa19741a)
- [483 - 2023-05-22](https://www.keypedia.com/records/483/sanofi-srl/ef6db67d-39bd-408f-9d63-88d1a0226efe)

## Related Officers

- [Richard Ledwidge](https://www.keypedia.com/people/richard-ledwidge/aaf4f089-8f7a-4d1f-b2e1-5f2e476a22a9)

Company: https://www.keypedia.com/companies/sanofi-srl/54ba861a-36eb-4486-a4ba-2a8194cdf7a5

Office: https://www.keypedia.com/offices/division-of-biotechnology-manufacturing/3e3018f1-aa48-4010-a554-96f557f17c55