# FDA 483 - Hovione FarmaCiencia SA - June 28, 2024

Source: https://www.keypedia.com/records/483/hovione-farmaciencia-sa/49bc3803-2ab7-4e81-b726-8119a4440306

> FDA 483 for Hovione FarmaCiencia SA on June 28, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hovione FarmaCiencia SA
- Inspection Date: 2024-06-28
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Hovione Farmaciencia SA, a drug manufacturer in Loures, Lisbon, Portugal, was cited for multiple significant deficiencies during an FDA inspection. Observations included inadequately qualified production equipment, insufficient investigation of manufacturing discrepancies, and a failure to maintain adequate production and process control procedures. Additionally, the firm was cited for issues with instrument calibration and qualification, and for not verifying the reliability of raw material supplier analyses.

## Related Documents

- [483 - 2017-03-13](https://www.keypedia.com/records/483/hovione-farmaciencia-sa/397cf0a7-9efe-46d8-964a-e06f103a4b7f)

## Related Officers

- [Pharmacy Intern/Certified Pharmacy Technician](https://www.keypedia.com/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)
- [Kenneth H. Williams](https://www.keypedia.com/people/kenneth-h-williams/20a225cd-a3d5-478f-ae04-2a8e119df8a6)

Company: https://www.keypedia.com/companies/hovione-farmaciencia-sa/e55a2dd8-7c1c-493d-8511-9761732d75ec

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