FDA WARNING_LETTER - ITL Asia Pacific Sdn Bhd - May 30, 2019

The FDA issued a Warning Letter to Plot 17B, Lorong Bemban 2 Bemban Industrial Estate, Batu Gajah, Perak, Malaysia, following an inspection from May 27-30, 2019. The firm manufactures blood collection devices, specifically the SampLok System with Hinged Lid, which were found to be adulterated under 21 U.S.C. § 351(h) due to non-conformity with the Quality System regulation (21 CFR Part 820). The firm's response to the FDA 483 was deemed inadequate.

Key violations include: 1) Failure to establish and maintain adequate design control procedures (21 CFR 820.30(a)) for the Class II SampLok Luer Kit. 2) Inadequate corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)), lacking identification of all quality data sources and statistical methodology. 3) Failure to validate processes not fully verifiable by inspection/test (21 CFR 820.75(a)), specifically the mixing process for the SampLok System. 4) Failure to establish and maintain procedures for validating device design (21 CFR 820.30(g)), evidenced by retesting rejected products at lower pressures. 5) Failure to maintain investigation records for customer complaints (21 CFR 820.198(e)). 6) Devices were also misbranded due to failure to adequately develop, maintain, and implement written Medical Device Reporting (MDR) procedures (21 CFR 803.17).

The FDA requires the firm to provide a written response within fifteen business days detailing specific corrective actions, prevention plans, and a timetable for implementation. Failure to correct these violations will result in continued refusal of admission for devices into the U.S. (detention without physical examination) and potential impact on federal contracts and premarket approvals.