Taicang Sheng Jia Medical Equipment Science & Technology Co. – FDA Warning Letter, Nov 12, 2014

On March 10, 2015, the FDA issued a Warning Letter to Taicang Sheng Jia Medical Equipment Science & Technology Co., Ltd. following an inspection from November 10-12, 2014. The inspection revealed that the firm, which manufactures wheeled stretchers (classified as devices), was in violation of the Federal Food, Drug, and Cosmetic Act.

The firm's devices were deemed misbranded under section 502(t)(2) of the Act due to failure to furnish required material or information under section 519 and 21 CFR Part 803 (Medical Device Reporting - MDR). Specifically, the firm failed to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17.

Additionally, the FDA noted nonconformances with section 501(h) of the Act, indicating deficiencies in the firm's quality system pertaining to current good manufacturing practice requirements (21 CFR Part 820). These included: 1. Failure to document all activities and results required under 21 CFR 820.100(b), such as personnel training for CAPA. 2. Failure to establish and maintain records of acceptable suppliers, contractors, and consultants (21 CFR 820.50(a)(3)), exemplified by the omission of a foreign hydraulic pump supplier from