He Gao Plastic Factory – FDA Warning Letter, Dec 21, 2011

The FDA issued a Warning Letter to He Gao Plastic Factory following a December 2011 inspection in China, identifying significant violations for its fluid-filled teething rings, classified as medical devices. The inspection revealed that the firm's manufacturing processes, facilities, and controls were not in conformity with the Quality System (QS) regulation (21 CFR Part 820), rendering its devices adulterated under section 501(h) of the Act. Key deficiencies included: failure to validate critical manufacturing processes (21 CFR 820.75(a)); inadequate corrective and preventive action (CAPA) procedures, lacking verification/validation and data analysis (21 CFR 820.100(a)); absence of documented process control procedures (21 CFR 820.70(a)); insufficient control over nonconforming products, including documentation and identification (21 CFR 820.90(a)); failure to prevent equipment and product contamination (21 CFR 820.70(e)); and deficiencies in maintaining Device Master Records (DMRs) (21 CFR 820.181) and Device History Records (DHRs), including missing procedures and inadequate content (21 CFR 820.184, 820.184(e)). Consequently, the firm's products are subject to refusal of admission into the U.S. (detention without physical examination). He Gao Plastic Factory must respond within fifteen working days, outlining specific corrective actions, prevention strategies, supporting documentation, and a timetable. Unresolved violations could also affect federal contracts, Class III device premarket approvals, and Certificates to Foreign Governments. The letter stressed the need for a thorough investigation into the root causes of these systemic quality assurance issues.