# FDA 483 - DEPUY (IRELAND) - December 09, 2016

Source: https://www.globalkeysolutions.net/records/483/depuy-ireland/863653cd-e260-4c37-8594-7d47da63e20f

> FDA 483 for DEPUY (IRELAND) on December 09, 2016. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DEPUY (IRELAND)
- Inspection Date: 2016-12-09
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of DePuy (Ireland), a medical device manufacturer in Cork, identified significant deficiencies in their quality system. Observations included inadequate device history records for Pinnacle Acetabular Cups, ineffective corrective and preventive action procedures, and insufficient validation of critical manufacturing processes. These issues indicate a lack of control over manufacturing operations and quality management.

## Related Officers

- [Frank J. Marciniak](https://www.globalkeysolutions.net/people/frank-j-marciniak/6995351a-6afc-4056-9692-d4aeb711dd92)

Company: https://www.globalkeysolutions.net/companies/depuy-ireland/b2d65a16-dd39-44d5-af2b-d81e3933e10e

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