FDA WARNING_LETTER - GVS Filter Technology UK Ltd - July 24, 2014

An FDA inspection of GVS Filter Technology UK Ltd. (Lancashire, UK) from July 21-24, 2014, found the firm's Class II air filters and spirometers adulterated, as their manufacturing controls did not conform to the Quality System (QS) regulation, 21 CFR Part 820. The firm's August 14, 2014, response to the FDA 483 was largely inadequate. Significant violations included failures in: establishing and documenting adequate Corrective and Preventive Action (CAPA) procedures (21 CFR 820.100(a), 820.100(b)); complaint handling procedures and recordkeeping (21 CFR 820.198, 820.198(e)); process validation (21 CFR 820.75(a)); documenting rework (21 CFR 820.90(b)(2)); nonconforming product disposition (21 CFR 820.90(b)(1)); device design validation (21 CFR 820.30(g)); purchasing document agreements (21 CFR 820.50(b)); acceptance activities documentation (21 CFR 820.80(e)); and statistically valid sampling methods (21 CFR 820.250(b)). A quality audit procedure deficiency (21 CFR 820.22) was also cited, though the firm's response was adequate for this specific point. As a result, the firm's medical devices face refusal of admission into the U.S. (detention without physical examination). The FDA mandates a written response within fifteen business days outlining specific corrective actions, prevention plans, and a timetable. Non-compliance could impact federal contracts and Class III device premarket approvals.