FDA 483 - Fareva Richmond, Inc. - May 23, 2025

Fareva Richmond, Inc. in Henrico, VA, was cited for significant deficiencies in equipment and utensil maintenance during an FDA inspection. Observations included a HEPA filter failure on a topical filling line that was not re-tested after motor replacement, and a backlog of over 230 overdue corrective maintenance items for various GMP equipment. These issues indicate a failure to prevent malfunctions and contamination that could impact drug product quality.