Precision Needle Manufacturing, Inc. – FDA Warning Letter, Jan 9, 2014

The FDA issued a Warning Letter to Precision Needle Manufacturing Company following an inspection from January 6-9, 2014, at their Gyunggii-Do, Republic of Korea facility. The firm manufactures guidewire introducers, saline flushing solution, and glass syringes, classified as devices. The inspection revealed that the devices are adulterated under section 501(h) of the Act, as manufacturing methods and controls do not conform to the Quality System regulation (21 CFR Part 820). Key violations include failures related to nonconforming product disposition procedures (21 CFR 820.90(b)(1)), product handling to prevent adverse effects (21 CFR 820.140), process validation for non-verifiable processes (21 CFR 820.75(a)), documentation of corrective and preventive actions (21 CFR 820.100(b)), inclusion of required information in complaint investigation records (21 CFR 820.198(e)), and defining control over suppliers and contractors (21 CFR 820.50(a)(2)). The firm's January 21, 2014, response to the FDA 483 was deemed inadequate for most observations, primarily because verification activities for corrective actions were incomplete or not yet conducted, with estimated completion dates extending to August 2014. The FDA requires a written response within fifteen business days detailing specific corrective and preventive actions, including documentation and timetables for systemic issues. Failure to comply may lead to further FDA action, including potential impact on federal contracts and premarket approvals for Class III devices. The letter emphasizes the firm's responsibility to investigate root causes and ensure overall compliance.