FDA WARNING_LETTER - Hangzhou Jinlin Medical Appliances Co., Ltd. - July 26, 2012

On December 12, 2012, the FDA issued a Warning Letter to Hangzhou Jinlin Medical Appliances Co., Ltd. following an inspection from July 23-26, 2012. The inspection revealed that the firm, which manufactures medical devices including tracheal tubes and oxygen masks, was in violation of the Federal Food, Drug, and Cosmetic Act.

The devices were deemed misbranded under section 502(t)(2) of the Act due to the firm's failure to comply with Medical Device Reporting (MDR) regulations (21 CFR Part 803). Specifically, the firm failed to adequately develop, maintain, and implement written MDR procedures (21 CFR 803.17). Deficiencies included a lack of internal systems for timely identification, communication, and evaluation of reportable events, insufficient instructions for event investigation and reportability determinations, and inadequate procedures for timely transmission of complete MDRs, including how to obtain and complete FDA Form 3500A and submission address. The firm's revised MDR procedure submitted post-inspection was found to be inadequate.

Additionally, the firm had significant quality system deficiencies, constituting nonconformances with current good manufacturing practice requirements (21 CFR Part 820). These included: 1. Failure to establish and maintain procedures for validating device design (21 CFR 820.30(g)), with inadequate design validation for a