FDA WARNING_LETTER - Royal Case Co., Inc. - July 01, 2015

On June 29-July 1, 2015, an FDA inspection of Royal Case Company, Inc. in Sherman, Texas, identified that the firm manufactures (initially imports) Cutaneous Electrode Garments, classified as medical devices. The inspection revealed these devices are adulterated under 21 U.S.C. § 351(h) because manufacturing, packing, storage, or installation methods do not conform to the Quality System regulation (21 CFR Part 820). The devices are also misbranded under 21 U.S.C. § 352(t)(2) for failing to provide required information under 21 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting).

Specific violations include: 1. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). The firm lacked complaint handling procedures for the imported cutaneous electrode garment device. 2. Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. The firm had no written MDR procedures for the device.

The firm's response dated July 15, 2015, was deemed inadequate as