FDA WARNING_LETTER - New May King Plastic Ltd - November 06, 2014

On April 13, 2015, the FDA issued a Warning Letter to New King May King Plastic, Ltd. following an inspection from November 3-6, 2014, in Shenzhen, China. The inspection revealed that the firm, which manufactures Class I and Class II massagers (medical devices), was not in conformity with the Quality System (QS) regulation (21 CFR Part 820), rendering their devices adulterated under section 501(h) of the Act. The firm's November 7, 2014, response to the FDA 483 was not evaluated due to lack of an English translation.

Key violations include: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: Procedures lacked requirements for analyzing quality data, verifying/validating CAPAs, and implementing/recording changes. 2. **Failure to maintain complaint files and procedures (21 CFR 820.198(a))**: Complaint handling procedures did not ensure timely processing or evaluation for FDA reporting, and complaints were not documented upon receipt. 3. **Failure to establish design transfer procedures (21 CFR 820.30(h))**: No procedure existed to translate design into production specifications. 4. **Failure to validate processes (21 CFR 820.