FDA WARNING_LETTER - Innovative Med Inc. - October 09, 2012

On March 19, 2013, the FDA issued a Warning Letter to Innovative Med Inc. following an inspection from October 3-9, 2012. The inspection found that the firm's Celluderm device, and other physical medicine therapeutic products, are adulterated under 21 U.S.C. § 351(h) due to non-conformity with the Quality System Regulation (21 CFR Part 820).

Specific cGMP violations include: - **Inadequate labeling procedures (21 CFR § 820.120):** Lack of documented approval for the vacuum therapy device, undefined labeling software in SOPs, and missing primary labels/labeling in device history records. - **Inadequate device master records (21 CFR § 820.181):** Incomplete specifications for vacuum therapy device DMRs and lack of drawings/assembly instructions for IM-CELL-E or IM-CELL-T devices. - **Inadequate acceptance procedures (21 CFR § 820.80):** Final inspection procedure for pump pressure inspection does not specify tools/equipment. - **Inadequate internal audit procedure implementation (21 CFR § 820.22):** Two internal auditors audited areas under their direct control, violating the firm's procedure.

Furthermore, the Celluderm device is adulterated under