FDA WARNING_LETTER - Teh Lin Prosthetic & Orthopedic, Inc. - August 25, 2011

On August 22-25, 2011, an FDA inspection of Teh Lin Prosthetic & Orthopedic, Inc. in Taipei, Taiwan, identified violations for external limb prosthetic components. The firm's devices are misbranded under 21 U.S.C. § 352(t)(2) due to failure to furnish required information under 21 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting). Specifically, the firm failed to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17.

Additionally, the inspection revealed nonconformances with the Quality System regulation (21 CFR Part 820), indicating deficiencies in the firm's quality system regarding current good manufacturing practice. These include failure to adequately maintain complaint files and establish/maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). Examples cited are complaints not being evaluated for MDR reporting and complaint files lacking returned/repaired warranty devices.

Due to these violations, the devices are subject to refusal of admission into the U.S. under 21 U.S.C. § 381(a) ("detention without physical examination"). The firm must provide a written response within fifteen business days detailing