FDA WARNING_LETTER - Nanentek Factory - September 05, 2014

On March 2, 2015, the FDA issued a Warning Letter to Nanentek, following an inspection from September 1-5, 2014, which found their FREND Instrument and Diagnostic Kits and Cell Counting Devices to be adulterated. The inspection revealed non-conformity with the Quality System regulation (21 CFR Part 820).

Key violations include: 1. Failure to establish and maintain corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)), specifically lacking documentation for CAPA C-14-06-016 regarding a motor drive malfunction. 2. Failure to establish and maintain procedures for controlling nonconforming product (21 CFR 820.90(a)), evidenced by undocumented nonconformance and investigation for an expired C-Chip Hemocytometer. 3. Failure to establish and maintain procedures for identifying valid statistical techniques (21 CFR 820.250(a)), as the number of products for a production process change validation was not statistically based.

The FDA requires a written response within fifteen business days detailing corrective actions, prevention plans, and a timetable for implementation. Failure to correct violations may impact federal contracts and Class III device premarket approvals. This letter is not exhaustive, and Nanentek is responsible for full compliance.