# FDA 483 - Octapharma Plasma, Inc. - December 20, 2024

Source: https://www.keypedia.com/records/483/octapharma-plasma-inc/6c3e6914-f94c-4fbf-ae99-f9a55ab26d15

> FDA 483 for Octapharma Plasma, Inc. on December 20, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Octapharma Plasma, Inc.
- Inspection Date: 2024-12-20
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Octapharma Plasma, Inc. in Terre Haute, IN, a source plasma center, identified a critical failure in aseptic technique during blood collection. A phlebotomist was observed contaminating a donor's venipuncture site after sterilization by touching it with a gloved hand. This lapse in procedure posed an imminent hazard, requiring immediate intervention.

## Related Documents

- [483 - 2024-12-20](https://www.keypedia.com/records/483/octapharma-plasma-inc/797d1e89-8543-4016-9de0-879a663c6e72)

## Related Officers

- [David A. Moore](https://www.keypedia.com/people/david-a-moore/361e4fe8-caf0-4320-963a-3838616850e2)
- [Lesley Mae P. Lutao](https://www.keypedia.com/people/lesley-mae-p-lutao/bfdcc755-28e5-4caf-91f9-b9579df4731e)

Company: https://www.keypedia.com/companies/octapharma-plasma-inc/446791a6-2ac0-4e7d-bd24-51bc4afcdcdf

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