# FDA 483 - Catalent Anagni SRL - July 16, 2024

Source: https://www.keypedia.com/records/483/catalent-anagni-srl/f4e5d169-d9a2-4ce7-92f8-ea2d42e53c19

> FDA 483 for Catalent Anagni SRL on July 16, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent Anagni SRL
- Inspection Date: 2024-07-16
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Catalent Anagni Srl, a drug product manufacturer in Anagni, Italy, was cited for significant deficiencies across its sterile manufacturing operations. Observations included inadequate procedures for preventing microbiological contamination, deficient environmental monitoring, and insufficient qualification of visual inspection and cleaning processes. These issues indicate a lack of robust controls over critical aspects of sterile drug product manufacturing and quality assurance.

## Related Officers

- [ Investigator, Consumer Safety Officer](https://www.keypedia.com/people/thuy-t-nguyen/1cfb5467-f0b7-49b8-85c1-00373692e35e)
- [Pharmaceutical Scientist](https://www.keypedia.com/people/ekaterina-allen/760a7817-8e5b-45f9-82ee-db6ca139a92e)
- [investigator](https://www.keypedia.com/people/ruo-hui-rose-xu/aa9de7e7-5115-4589-b5bf-0d9b87726d79)

Company: https://www.keypedia.com/companies/catalent-anagni-srl/1b1c4afa-1475-4112-9b72-7a77bf647453

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