# FDA 483 - BioLife Plasma Services L.P. - November 22, 2024

Source: https://www.globalkeysolutions.net/records/483/biolife-plasma-services-lp/47778c68-ebcf-43b8-9dd3-1e0c93faaaf3

> FDA 483 for BioLife Plasma Services L.P. on November 22, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioLife Plasma Services L.P.
- Inspection Date: 2024-11-22
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: An FDA inspection of BioLife Plasma Services L.P. in Arlington, TX, a plasmapheresis center, revealed a significant failure to maintain donor, quality control, and general records. The inspection found issues with labeling QC vials with open/expiration dates and obtaining proper donor consent due to equipment malfunction. These deficiencies indicate a lack of adherence to established procedures for critical record-keeping.

## Related Documents

- [483 - 2021-06-08](https://www.globalkeysolutions.net/records/483/biolife-plasma-services-lp/d7de70ff-a1ce-4870-b560-bdada868d767)

## Related Officers

- [Michelle Paxon](https://www.globalkeysolutions.net/people/michelle-paxon/1748c593-7d85-4ede-a5f4-8c0a33c21d52)

Company: https://www.globalkeysolutions.net/companies/biolife-plasma-services-lp/4da1f7df-1bb7-49cd-b6f5-a15817f6703b

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9