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

Source: https://www.keypedia.com/records/483/catalent-anagni-srl/3ebb2fcb-e749-46a3-8f0e-7875882a7a06

> 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: Baltimore District Office
- Summary: An FDA inspection conducted at Catalent Anagni Srl in Anagni, Italy, from July 9-13, 15-16, 2024, identified significant deficiencies in its drug product manufacturing processes. The observations, detailed in an FDA 483 form, highlight concerns regarding adherence to regulatory expectations for sterile drug product manufacturing. Key issues include inadequate procedures to prevent microbiological contamination, such as insufficient operator qualification for aseptic interventions and poor aseptic techniques observed during equipment setup. The facility's environmental monitoring program was found deficient, with shortcomings in its process qualification and routine sampling. Furthermore, the qualification of visual inspection procedures for injectable products was inadequate, stemming from issues with Automatic Visual Inspection (AVI) machine validation, improper challenge kit use, and an unsuitable AQL inspection environment. Deficiencies in equipment cleaning and maintenance, including disinfectant contact time, were also noted. Finally, the inspection cited inadequate qualification and calibration of manufacturing equipment, as well as a lack of scientific justification for in-process control sampling plans and insufficient monitoring of critical process parameters. These observations necessitate prompt corrective and preventive actions from Catalent Anagni to ensure compliance with current Good Manufacturing Practices and the quality and safety of their drug products.

## Related Documents

- [483 - 2024-07-16](https://www.keypedia.com/records/483/catalent-anagni-srl/f4e5d169-d9a2-4ce7-92f8-ea2d42e53c19)

## Related Officers

- [ Investigator, Consumer Safety Officer](https://www.keypedia.com/people/thuy-t-nguyen/1cfb5467-f0b7-49b8-85c1-00373692e35e)
- [Consumer Safety Officer at FDA](https://www.keypedia.com/people/dianne-h-milazzo/3059779d-51f5-4622-8f8d-7766c76b47d5)
- [Pharmaceutical Scientist](https://www.keypedia.com/people/ekaterina-allen/760a7817-8e5b-45f9-82ee-db6ca139a92e)
- [Ruo Xu](https://www.keypedia.com/people/ruo-xu/2890845a-5ac0-49e5-9389-65ff0c0cc313)

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

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa