# FDA WARNING_LETTER - naimco inc  - August 24, 2011

Source: https://www.keypedia.com/records/warning_letter/naimco-inc/fb803445-fabe-491f-b9a9-2e119baa520f

> FDA WARNING_LETTER for naimco inc  on August 24, 2011. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: naimco inc 
- Inspection Date: 2011-08-24
- Product Type: Devices
- Office Name: Department of Health and Human Services
- Summary: On August 15-19 and 24, 2011, an FDA inspection of NAImco Inc., dba Rich-Mar, Inc. in Chattanooga, Tennessee, revealed that their Ultrasound/Stimulator Electro-Therapy devices and other products were adulterated under Section 501(h) of the Act [21 USC 351(h)]. The manufacturing, packing, storage, or installation methods and controls did not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations included:
- Failure to review and evaluate all complaints, particularly those involving patient shocks and burns, as required by 21 CFR 820.198(b).
- Failure to establish adequate procedures for evaluating complaints for Medical Device Reporting (MDR) under 21 CFR Part 803, as required by 21 CFR 820.198(a)(3).
- Inadequate corrective and preventive action (CAPA) procedures, including verification of effectiveness and dissemination of quality problem information (21 CFR 820.100(a)).
- Lack of adequate rework procedures, documentation, and retesting (21 CFR 820.90(b)(2)).
- Failure to ensure purchased products and services conform to requirements, including incomplete supplier evaluations and lack of an approved suppliers list (21

## Related Officers

- [Patricia K. Schafer](https://www.keypedia.com/people/patricia-k-schafer/34b879a1-8a40-40f0-a526-e56ac62665e9)

Company: https://www.keypedia.com/companies/naimco-inc/27652153-685e-4b33-850e-82843c760320

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861