FDA WARNING_LETTER - GUANGDONG BIOLIGHT MEDITECH CO., LTD - August 23, 2012

The FDA issued a Warning Letter to Guangdong Biolight Meditech Co., Ltd. following an inspection from August 20-23, 2012, at their Zhuhai, China facility, which manufactures physiological patient monitors and accessories. The inspection revealed that the firm's devices are adulterated under 21 U.S.C. § 351(h) because their manufacturing, packing, storage, or installation methods do not conform to the Quality System (QS) regulation, 21 CFR Part 820. Additionally, devices were found to be misbranded under 21 U.S.C. § 352(t)(2) and § 352(b).

Key QS violations include failures to: maintain complaint files and procedures (21 CFR 820.198(a)), maintain investigation records (21 CFR 820.198(e)), establish design validation procedures (21 CFR 820.30(g)), establish design verification procedures (21 CFR 820.30(f)), implement corrective and preventive action procedures (21 CFR 820.100(a)), control nonconforming product (21 CFR 820.90(a)), conduct formal design reviews (21 CFR 820.30(e)), and maintain complete device history records (21 CFR 820.184).

Misbranding violations include the failure to develop and implement written Medical Device Reporting (MDR) procedures (21 CFR 803.17) and the failure of FingerTrip Pulse Oximeter labels to contain the manufacturer's name and place of business (21 U.S.C. 352(b), 21 CFR 801.1).

The firm's September 11, 2012, response to the FDA 483 was deemed inadequate as it lacked documentation of corrections and corrective actions. The FDA requires a written response within fifteen business days detailing specific steps taken, including systemic corrective actions, documentation, and a timetable for completion. Failure to correct violations may impact premarket approval applications, Certificates to Foreign Governments, and federal contracts.