FDA WARNING_LETTER - InControl Medical, LLC - August 21, 2012

This FDA Warning Letter, dated MIN 13 – 08, was issued to InControl Medical, LLC, following an inspection from August 14-16, 21, 2012. The inspection revealed that the firm's InTone™ non-implanted electrical stimulator, a device for female urinary incontinence, was adulterated under section 501(h) of the Act, as its manufacturing, packing, storage, or installation methods did not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Failure to establish and maintain an adequate organizational structure (21 CFR 820.20(b))**: Lacking defined responsibilities, authority, resources, trained personnel, and a documented management representative for quality. 2. **Failure to perform quality audits (21 CFR 820.22)**: No internal audit schedule, and the firm lacked a "Quality department" or "Quality manager" as referenced in their procedure. 3. **Failure to establish and maintain a design history file (21 CFR 820.30(j))**: The InTone™ DHF did not demonstrate design development in accordance with an approved plan and QS requirements; work instructions and design control procedures were approved after product shipment. 4. **Failure to establish adequate procedures for design validation (2