FDA WARNING_LETTER - kaiya medical ( - July 24, 2014

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