# FDA 483 - Plastiape Spa - July 30, 2015

Source: https://www.keypedia.com/records/483/plastiape-spa/11282775-32af-4d2f-beba-1eaa9b7231b8

> FDA 483 for Plastiape Spa on July 30, 2015. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Plastiape Spa
- Inspection Date: 2015-07-30
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Plastiape Spa, a medical device manufacturer in Osnago, Italy, revealed significant deficiencies in its quality system. Observations included inadequate procedures for supplier corrective actions, management review, and internal quality audits. These issues indicate a lack of robust oversight and control over critical quality processes.

## Related Officers

- [Vascular Neurologist/Neurohospitalist/Medical Officer](https://www.keypedia.com/people/claudette-d-brooks/10f30b8f-2d20-4f92-84c1-862b31b81ce1)

Company: https://www.keypedia.com/companies/plastiape-spa/3be49df2-77d9-4c3e-85ba-8e4704ef2599

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