# FDA 483 - BioLife Plasma Services L.P. - October 17, 2019

Source: https://www.keypedia.com/records/483/biolife-plasma-services-lp/b0a6ef6e-95fa-492e-a230-9b6abbb8a52a

> FDA 483 for BioLife Plasma Services L.P. on October 17, 2019. 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: 2019-10-17
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of BioLife Plasma Services L.P. in Grandville, MI, a plasmapheresis collection center, revealed a significant issue with equipment maintenance. The firm failed to perform regularly scheduled calibration and preventative maintenance on a plasmapheresis machine used for source plasma collections. This indicates a lapse in adhering to standard operating procedures for critical equipment.

## Related Officers

- [Erma Zaimova](https://www.keypedia.com/people/erma-zaimova/87da23ad-48bb-4096-9d8a-e8511c6b5c98)

Company: https://www.keypedia.com/companies/biolife-plasma-services-lp/a55b2950-6bf2-4868-8d8c-de08e5b84506

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0