# FDA WARNING_LETTER - kaiya medical ( - July 24, 2014

Source: https://www.keypedia.com/records/warning_letter/kaiya-medical/f8d1d89a-f7fd-46d3-a90f-5b39389f2c30

> FDA WARNING_LETTER for kaiya medical ( on July 24, 2014. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: kaiya medical (
- Inspection Date: 2014-07-24
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On January 12, 2015, the FDA issued a Warning Letter to Kaiya Medical (dba Care Medical-Foshan) following an inspection from July 21-24, 2014, in Guangdong, China. The inspection found that the firm's nebulizers are adulterated under 21 U.S.C. § 351(h) because their manufacturing, packing, storage, or installation methods do not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations include:
1.  **Failure to establish and maintain complaint procedures (21 CFR 820.198):** Individual device malfunction complaints were not investigated, and complaint files lacked dates, investigation results, corrective actions, and replies.
2.  **Failure to maintain design history files (21 CFR 820.30(j)):** The design input for the KYWH2001 nebulizer lacked functional performance requirements for the integrated system with accessories, despite being addressed in verification/validation.
3.  **Failure to control design changes (21 CFR 820.30(i)):** The design control procedure did not explicitly require verification and validation of changes when necessary.
4.  **Failure to control changes to specifications/procedures (21 CFR 820.70(b)):** Finished KY

## Related Officers

- [President](https://www.keypedia.com/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)
- [Piper Medical](https://www.keypedia.com/people/piper-medical/e48b46c7-1dde-4ac5-8d0a-6d0522720e65)

Company: https://www.keypedia.com/companies/kaiya-medical/d53024f3-c28c-4a05-8d8f-dd865d34bfb6

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