# FDA 483 - Octapharma Plasma Inc - April 27, 2022

Source: https://www.globalkeysolutions.net/records/483/octapharma-plasma-inc/829a34af-a125-4130-ba70-aecf0ea931c4

> FDA 483 for Octapharma Plasma Inc on April 27, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Octapharma Plasma Inc
- Inspection Date: 2022-04-27
- Product Type: biologics
- Office Name: Cincinnati District Office
- Summary: Octapharma Plasma Inc. in Reynoldsburg, OH, was inspected by the FDA, resulting in six observations related to deviations from written standard operating procedures. The observations primarily concern improper aseptic technique during donor disconnection, incorrect donor screening and physical examination procedures, and failures in plasma processing and quality control for equipment. These issues indicate a lack of consistent adherence to established protocols for source plasma collection and processing.

## Related Officers

- [Nisha C. Patel](https://www.globalkeysolutions.net/people/nisha-c-patel/1b38764f-c7bc-4f90-9af1-54989ad6d59c)

Company: https://www.globalkeysolutions.net/companies/octapharma-plasma-inc/43b6ef39-9124-4bbc-8b9a-52941442b326

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22