# FDA 483 - Octapharma Plasma Inc - September 10, 2021

Source: https://www.globalkeysolutions.net/records/483/octapharma-plasma-inc/30b8d651-b22f-421e-95ee-330042d2a757

> FDA 483 for Octapharma Plasma Inc on September 10, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Octapharma Plasma Inc
- Inspection Date: 2021-09-10
- Product Type: biologics
- Office Name: Cincinnati District Office
- Summary: Octapharma Plasma Inc. in Columbus, OH, was inspected and received a Form 483 with four observations related to plasma collection and processing. The observations highlight issues with donor suitability determination due to incorrect medication indications, lack of certified CPR personnel, inadequate privacy for donor examinations, and multiple instances of failure to follow written standard operating procedures. These findings indicate deficiencies in critical aspects of donor screening, facility operations, and adherence to established protocols for blood and blood component collection.

## Related Officers

- [Nisha C. Patel](https://www.globalkeysolutions.net/people/nisha-c-patel/1b38764f-c7bc-4f90-9af1-54989ad6d59c)
- [Nancy L. Neiger](https://www.globalkeysolutions.net/people/nancy-l-neiger/c3209528-eeb3-4a5f-88b1-f503798ed4c5)

Company: https://www.globalkeysolutions.net/companies/octapharma-plasma-inc/49164273-1499-43e1-99cc-fa8363b42185

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