# FDA 483 - Grifols Therapeutics LLC - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/grifols-therapeutics-llc/7dbd0e3f-4f85-4319-b54c-fcbb5a82d5d4

> 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: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Grifols Therapeutics LLC in Clayton, NC, revealed significant deficiencies in quality control and manufacturing processes. Key issues include inadequate investigations into adverse event trends leading to product recalls, widespread failures in visual inspection personnel requalification without proper follow-up, and critical shortcomings in environmental monitoring and media growth promotion testing within aseptic processing areas. These findings indicate a lack of robust systems to ensure product quality and patient safety.

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- [483 - 2023-09-01](https://www.globalkeysolutions.net/records/483/grifols-therapeutics-llc/a0027827-e11c-4401-8d9e-736ea37fded6)

## Related Officers

- [Cynthia Jim](https://www.globalkeysolutions.net/people/cynthia-jim/e0f1c8a7-d787-442a-911c-61e37cd806a6)

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