# FDA 483 - Octapharma Plasma, Inc. - September 23, 2019

Source: https://www.globalkeysolutions.net/records/483/octapharma-plasma-inc/cfa93586-70c5-4674-8f0e-f07ce90a08e8

> FDA 483 for Octapharma Plasma, Inc. on September 23, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Octapharma Plasma, Inc.
- Inspection Date: 2019-09-23
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Octapharma Plasma, Inc.'s Source Plasma Donor Center in Forestville, MD, revealed a critical failure to maintain donor records. Specifically, the firm did not retain notification letters for deferred donors who tested positive for serious communicable diseases like HIV, HCV, and HBsAg. This lapse in record-keeping raises concerns about proper donor management and public health safety.

## Related Officers

- [La-tasha M. Gunter](https://www.globalkeysolutions.net/people/la-tasha-m-gunter/db9cd9cf-db0a-4c31-9f7c-24760750f34d)

Company: https://www.globalkeysolutions.net/companies/octapharma-plasma-inc/e0dc45cc-d385-40df-bbf1-3cd5148cbbfc

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e