# FDA 483 - Grifols Therapeutics LLC - Unknown Date

Source: https://www.keypedia.com/records/483/grifols-therapeutics-llc/179dc664-3ece-4464-a4cb-445c085a3e16

> FDA 483 for Grifols Therapeutics LLC on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Grifols Therapeutics LLC
- Product Type: biologics
- Office Name: Office of Biological Products Operations - Division I
- Summary: Grifols Therapeutics, Inc. in Clayton, NC, was inspected and cited for multiple quality system deficiencies. Observations included failures to investigate the root cause of leaking fill lines, inadequate work order investigations, deficient written procedures, and various facility and equipment issues. These findings indicate a need for improved quality oversight and adherence to manufacturing controls.

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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