# FDA 483 - Indena S.p.A. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/indena-spa/7e415097-5c9d-452d-a7ae-474e4513041e

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

---

## Details

- Record Type: 483
- Company Name: Indena S.p.A.
- Product Type: drugs
- Office Name: FDA District Office — Silver Springs, Maryland
- Summary: An FDA inspection of Indena S.p.A, an API manufacturer in Settala, Italy, revealed significant deficiencies in their quality system. The firm failed to adequately investigate repeated deviations and out-of-specification (OOS) results, implement appropriate corrective actions, and ensure data integrity for manual entries. Recurring LAL endotoxin OOS results were not thoroughly investigated, and an instrument malfunction deviation lacked proper event capture, justification of actions, and impact assessment.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/junho-pak/4abe53fb-ad20-490d-9e71-6216a9f863f5)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/sangeeta-m-khurana/bed4533f-a9aa-47c5-9e0b-f20ad36461aa)

Company: https://www.globalkeysolutions.net/companies/indena-spa/bc7187ac-74c4-4f04-bd1c-0d888424e076

Office: https://www.globalkeysolutions.net/offices/fda-district-office-silver-springs-maryland/079bb75c-3759-4baa-baed-4159edd64552