# FDA 483 - Grifols Therapeutics LLC - Unknown Date

Source: https://www.keypedia.com/records/483/grifols-therapeutics-llc/9b3fca0f-5880-4793-ac91-143400fc36bf

> 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: Atlanta District Office
- Summary: Grifols Therapeutics LLC, a biologic drug manufacturer in Clayton, North Carolina, was cited for significant deficiencies in its aseptic processing procedures. The inspection revealed inadequate documentation for media fill reconciliation and a lack of periodic review for filling line intrusions. Additionally, the firm's bioburden monitoring for pre-sterile bulks was found to be inadequate, with issues in speciation and investigation of microbial findings.

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## Related Officers

- [Laurel A. Beer](https://www.keypedia.com/people/laurel-a-beer/0ac1e74f-0ff6-4db6-a0e8-0c3fb013720e)
- [investigator](https://www.keypedia.com/people/susan-m-jackson/2a4e01d1-8761-4d40-b493-69a4163473bb)
- [Gena Arcy, CSO](https://www.keypedia.com/people/gena-arcy-cso/5e73742f-22df-4750-82a8-430f86192916)

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

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7