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

Source: https://www.keypedia.com/records/warning_letter/innovative-med-inc/f0b92819-f05f-46ea-a73c-dd654965081b

> FDA WARNING_LETTER for Innovative Med Inc. on October 09, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Innovative Med Inc.
- Inspection Date: 2012-10-09
- Product Type: Devices
- Office Name: Los Angeles District Office
- Summary: 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

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## Related Officers

- [Director](https://www.keypedia.com/people/alonza-e-cruse/650e3631-3f99-45f7-863e-3a35c44be485)

Company: https://www.keypedia.com/companies/innovative-med-inc/aee44d09-6f76-45aa-b532-ac3501972fd9

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b