# FDA 483 - Hovione FarmaCiencia SA - March 13, 2017

Source: https://www.keypedia.com/records/483/hovione-farmaciencia-sa/397cf0a7-9efe-46d8-964a-e06f103a4b7f

> FDA 483 for Hovione FarmaCiencia SA on March 13, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hovione FarmaCiencia SA
- Inspection Date: 2017-03-13
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Hovione Farmaciencia SA, an API manufacturer in Loures, Portugal, was inspected and cited for multiple deficiencies. The inspection revealed significant issues with quality control unit procedures, including inadequate deviation investigations and recall processes. Additionally, the firm failed to maintain proper laboratory controls, ensure adequate employee training, correctly segregate rejected materials, and keep its manufacturing buildings in good repair.

## Related Documents

- [483 - 2024-06-28](https://www.keypedia.com/records/483/hovione-farmaciencia-sa/49bc3803-2ab7-4e81-b726-8119a4440306)

## Related Officers

- [investigator](https://www.keypedia.com/people/laura-fontan/b27b02a3-9ab1-49df-b2bc-ee936b69d76a)
- [Drug Investigator](https://www.keypedia.com/people/deyaa-shaheen/ebbabce5-347c-4de4-abed-ba9da11c26ed)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd