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483
•MCGH/PPG Reproductive Laboratory, LLC•July 31, 2026

MCGH/PPG Reproductive Laboratory, LLC – FDA 483, Jul 31, 2026

Record Details

MCRH PFC Reproductive Laboratory, LLC in Augusta, GA was inspected regarding its reproductive firm operations. The inspection revealed a significant issue where human cells, tissues, and cellular and tissue-based products (HCT/Ps), specifically fertilized oocytes, were not appropriately labeled with warning statements despite a donor testing reactive for a communicable disease. This indicates a serious lapse in donor eligibility and product labeling protocols.

Company
MCGH/PPG Reproductive Laboratory, LLC
Inspection date
July 31, 2026
Product type
biologics
Office
Atlanta District Office
People
  • Nisha C. Patel
  • Steven D. Banks
View Company Profile

ID · 082f1aed-cd35-4a99-99ab-214c4ce33db3

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