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

Fareva Richmond, Inc. in Henrico, VA, received an FDA Form 483 for significant equipment maintenance deficiencies. Inspectors noted that a HEPA filter re-test for a topical product line was never completed after a motor replacement, leading to production without confirmed filter integrity for nearly a year. Additionally, the firm had over 230 overdue corrective maintenance items for various GMP equipment.