# FDA 483 - Grifols Therapeutics LLC - April 01, 2014

Source: https://www.keypedia.com/records/483/grifols-therapeutics-llc/fe4782b9-258b-4f75-953d-f2ca64b7f6eb

> FDA 483 for Grifols Therapeutics LLC on April 01, 2014. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Grifols Therapeutics LLC
- Inspection Date: 2014-04-01
- Product Type: biologics
- Office Name: Office of Biological Products Operations - Division I
- Summary: Grifols Therapeutics Inc. in Clayton, NC, was inspected regarding its plasma fractionation operations. The inspection revealed significant issues including product stability concerns with Albumin, incomplete sterility investigations for Prolastin, inadequate media fill accountability, and poor aseptic practices during filling. Additionally, several facility and equipment maintenance deficiencies were noted, indicating a moderate level of severity.

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## Related Officers

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Company: https://www.keypedia.com/companies/grifols-therapeutics-llc/2e4dd489-4e70-4ef7-a1f8-f0267f91fab5

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