FDA WARNING_LETTER - Insightra Medical Inc - February 24, 2015

On May 21, 2015, the FDA issued a Warning Letter to Insightra Medical, Inc. following an inspection from February 19-24, 2015. The inspection revealed that the firm's Intra-Aortic Balloon Catheters and Inguinal Hernia Implants were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System regulation (21 CFR Part 820).

Key violations included: 1. **Failure to adequately establish complaint handling procedures (21 CFR Part 820.198(a))**: The "Product Complaint Handling and Post Market Surveillance Procedure" (RA2-0007 Rev 15) lacked delineated investigation levels and procedures. Four out of twelve reviewed complaints were not adequately investigated to determine root cause, with instances of unreviewed patient information, videos, and lack of attempts to contact end-users or perform alternative investigations when products were not returned. The procedure also lacked allowances for complaint file closure beyond 30 days. Insightra's response indicated in-progress revisions to address these issues, with an estimated completion date of June 30, 2015.

2. **Failure to adequately develop, maintain, and implement written Medical Device Reporting (MDR) procedures (21 CFR 803.17)**: