# FDA 483 - Grifols Therapeutics LLC - September 01, 2023

Source: https://www.globalkeysolutions.net/records/483/grifols-therapeutics-llc/a0027827-e11c-4401-8d9e-736ea37fded6

> FDA 483 for Grifols Therapeutics LLC on September 01, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Grifols Therapeutics LLC
- Inspection Date: 2023-09-01
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Grifols Therapeutics LLC in Clayton, NC, identified several significant deficiencies in their biologic drug manufacturing operations. Key issues included inadequate control over production processes, failures in equipment preventive maintenance, and a lack of established written procedures for critical tasks. Additionally, the facility exhibited poor maintenance of freezers and insufficient control of utility support systems.

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## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/yonggang-wang/5c7dd00f-f810-4f86-9c78-51ae7f4b8acd)
- [Kula Jha, Ph.D.](https://www.globalkeysolutions.net/people/kula-jha-phd/9f0eddc7-93bc-40c1-a0f0-863a82f5ff03)
- [Bradley Dworsak, Ph.D.](https://www.globalkeysolutions.net/people/bradley-dworsak-phd/2146d880-72bf-4a00-86d8-6598939b0fa9)

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

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