# FDA 483 - Avara Liscate Pharmaceutical Services SPA - December 06, 2022

Source: https://www.keypedia.com/records/483/avara-liscate-pharmaceutical-services-spa/57ade3fa-5b27-4869-9303-934d3792b63d

> FDA 483 for Avara Liscate Pharmaceutical Services SPA on December 06, 2022. 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: 2022-12-06
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Avara Liscate Pharmaceutical Services S.r.l. in Liscate, Italy, a contract drug manufacturer, revealed significant deficiencies in quality control and record-keeping. The firm failed to adequately investigate product complaints, out-of-specification deviations, and ensure the effectiveness of corrective actions. Additionally, the facility lacked proper microbiological control for equipment and maintained deficient batch production records.

## Related Documents

- [483 - 2014-05-13](https://www.keypedia.com/records/483/avara-liscate-pharmaceutical-services-spa/4230090c-0329-4637-be4e-6cbc5e8c007a)

## Related Officers

- [William Leonard](https://www.keypedia.com/people/william-leonard/1f11ece4-597c-4d3e-aac4-46f8ea404ec3)

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

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1