# FDA 483 - Latina Pharma S.p.A. - Unknown Date

Source: https://www.keypedia.com/records/483/latina-pharma-spa/5b49a901-90de-4304-b852-d0b8f1913e86

> FDA 483 for Latina Pharma S.p.A. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Latina Pharma S.p.A.
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Corden Pharma Latina S.p.A. in Sermoneta, Italy, revealed significant deficiencies across its quality, production, and laboratory systems. The firm failed to thoroughly investigate discrepancies, maintain adequate aseptic processing controls, validate reprocessing procedures, ensure reliable laboratory data, and properly validate test methods for sterile injectable products. These issues indicate a serious lack of control over manufacturing processes and product quality.

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Company: https://www.keypedia.com/companies/latina-pharma-spa/9cb7e758-39a0-4b4c-bfad-93d1468f5d38

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321