FDA WARNING_LETTER - Spineology, Inc. - June 30, 2010

The FDA issued a Warning Letter to Spineology, Inc. on September 22, 2010, following inspections from June 9-30, 2010, at Spineology and from September 14-December 2, 2009, at clinical investigator Dr. Miguelangelo Perez-Cruet's site. The inspections assessed compliance with federal regulations for the OptiMesh for Lumbar Interbody Fusion (OLIF) Study, Investigational Device Exemption (IDE) (b)(4), for the OptiMesh 1500S for Interbody Fusion device.

The letter cited serious violations of 21 CFR Part 812 – Investigational Device Exemptions. Spineology failed to ensure adequate monitoring of the investigation (21 CFR 812.40), as evidenced by Dr. Perez-Cruet's site having study forms signed by the Clinical Trial Study Coordinator instead of the investigator, despite subsequent monitoring visits. Spineology also failed to secure the investigator's compliance with the signed agreement and investigational plan (21 CFR 812.46(a)). This was demonstrated by discrepancies in Concomitant Medication Forms for six subjects at Dr. Perez-Cruet's site, leading to incomplete data submission for premarket notification (b)(4).

Spineology's July 14, 2010, response was deemed inadequate for