# FDA 483 - Avara Liscate Pharmaceutical Services SPA - May 13, 2014

Source: https://www.keypedia.com/records/483/avara-liscate-pharmaceutical-services-spa/4230090c-0329-4637-be4e-6cbc5e8c007a

> FDA 483 for Avara Liscate Pharmaceutical Services SPA on May 13, 2014. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Avara Liscate Pharmaceutical Services SPA
- Inspection Date: 2014-05-13
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Hospira S.p.A. in Liscate, Italy, a sterile drug manufacturer, was inspected by the FDA. The inspection revealed significant deficiencies in aseptic processing, including inadequate sterilization validation, environmental monitoring, and cleaning procedures. Additionally, issues with data integrity, laboratory record-keeping, and complaint investigations were noted, indicating a lack of robust quality control systems.

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## Related Officers

- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)
- [Lynda L. Perry](https://www.keypedia.com/people/lynda-l-perry/7a3fa780-f0f4-4e8b-9617-f708ffd46668)

Company: https://www.keypedia.com/companies/avara-liscate-pharmaceutical-services-spa/2dee93ec-8dc9-420b-b20d-da7f8948cf04

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8