# FDA 483 - Blood Center (The) Mandeville Donor Center - March 11, 2022

Source: https://www.keypedia.com/records/483/blood-center-the-mandeville-donor-center/3ebfd809-a3fb-4718-aeb6-8fc9507b8b91

> FDA 483 for Blood Center (The) Mandeville Donor Center on March 11, 2022. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Blood Center (The) Mandeville Donor Center
- Inspection Date: 2022-03-11
- Product Type: biologics
- Office Name: New Orleans District Office
- Summary: The FDA issued a Form 483 to The Blood Center Mandeville Donor Center following an inspection on March 11, 2022. The inspection revealed that personnel responsible for blood collection lacked adequate training and experience, specifically citing a donor technician's failure to adhere to standard operating procedures during a medical history and physical exam for a directed donor. This included misclassifying a directed donor, not presenting the consent form pre-donation, and failing to instruct the donor to review educational materials.

## Related Officers

- [Investigator at U.S.FDA](https://www.keypedia.com/people/barbara-t-carmichael/4c451805-e327-450d-b2e5-48a40f6232fe)
- [FDA_PERSONNEL](https://www.keypedia.com/people/edward-a-brunt/f823f6cb-7fb1-422b-b022-cb0d673f6210)

Company: https://www.keypedia.com/companies/blood-center-the-mandeville-donor-center/3343435c-0a61-4e26-8591-7cf88a199241

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea