Command Medical Products LLC – FDA EIR, Nov 30, 2018

The FDA conducted an inspection of Command Medical Products, Inc., a medical device contract manufacturer in Ormond Beach, FL, from November 20-30, 2018. This for-cause inspection, carried out under Compliance Program 7382.845 for medical device manufacturers, revealed multiple deficiencies, some of which were repeated from a previous inspection. The regulatory framework for these violations falls under the Quality System Regulation (21 CFR 820).

Key violations, detailed in a Form FDA 483, included inadequately established procedures for controlling environmental conditions (21 CFR 820.70(c)), specifically regarding clean room certification, HEPA filter maintenance, and monitoring suitability. Procedures for Corrective and Preventive Action (CAPA) were also insufficient, lacking defined frequencies for quality data analysis and requirements for verification/validation before implementation (21 CFR 820.100(a)). Complaint handling procedures were found deficient in identifying underlying causes and documenting investigations (21 CFR 820.198(a)). Lastly, purchasing controls were inadequate, with overdue on-site audits for critical suppliers and a lack of evidence for population verification from contract sterilizers (21 CFR 820.50).

Management, represented by Mr. Robert F. Wise, promised corrections and indicated a response would be submitted within fifteen business days. The FDA warned that failure to implement adequate corrections could result in further regulatory action, including a Warning Letter, seizure, or injunction.