# FDA WARNING_LETTER - Nanentek Factory - September 05, 2014

Source: https://www.keypedia.com/records/warning_letter/nanentek-factory/3b9d365a-03b8-4749-b0d6-23d240b8b38c

> FDA WARNING_LETTER for Nanentek Factory on September 05, 2014. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Nanentek Factory
- Inspection Date: 2014-09-05
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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.

## Related Officers

- [Director](https://www.keypedia.com/people/alberto-gutierrez/ec16aa77-9dd3-4aff-aae4-1540ea96c5b8)

Company: https://www.keypedia.com/companies/nanentek-factory/6bc982b0-2a5b-4c60-bcfd-91faebbd4530

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7