# FDA 483 - Piedmont Reproductive Endocrinology Group, PA - January 09, 2026

Source: https://www.keypedia.com/records/483/piedmont-reproductive-endocrinology-group-pa/482ac3a2-191c-4358-9644-2fb799d4d6a2

> FDA 483 for Piedmont Reproductive Endocrinology Group, PA on January 09, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Piedmont Reproductive Endocrinology Group, PA
- Inspection Date: 2026-01-09
- Product Type: biologics
- Office Name: FDA District Office — Atlanta, Georgia
- Summary: Piedmont Reproductive Endocrinology Group, PA in West Columbia, SC was inspected regarding its HCT/P operations, specifically anonymous oocyte donor screening. The inspection revealed that the firm used abbreviated donor screening procedures for donors who lacked a complete screening within the previous six months. Additionally, the firm failed to establish and maintain written procedures for HCT/P donor screening, particularly for its abbreviated assessment form.

## Related Officers

- [Amy A. Johnson](https://www.keypedia.com/people/amy-a-johnson/9933f793-503f-45c5-8837-d46134c20e09)

Company: https://www.keypedia.com/companies/piedmont-reproductive-endocrinology-group-pa/c852a71c-7b48-4de7-80e0-4999c4e09a02

Office: https://www.keypedia.com/offices/fda-district-office-atlanta-georgia/bae3b8c4-4161-4e9f-b5d1-e0e80b6abd43