FDA WARNING_LETTER - Ohio Medical Corporation - November 26, 2024

On April 9, 2025, the FDA issued a Warning Letter to Ms. Zhang regarding an inspection of their firm, located at 2075 Zanker Road, San Jose, CA, from October 28, 2024, to November 26, 2024. The firm manufactures bronchoscopes and accessories (Galaxy System), which are classified as devices. The inspection revealed these devices are adulterated under 21 U.S.C. § 351(h) because manufacturing, packing, storage, or installation methods do not conform to Quality System regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: The firm's CAPA procedure (SOP-019 Rev. B) was inadequate, as investigations for CAPA 24-007 and CAPA 23-005 failed to determine root causes or adequately evaluate issues like lot-to-lot variations and supplier quality. 2. **Failure to establish and maintain complaint procedures (21 CFR 820.198(a))**: The "Complaint Management" procedure (SOP-025, Rev. G) was not followed, with inadequate investigations for complaints #00003531,