FDA WARNING_LETTER - Cytophil, Inc. - February 13, 2014

The FDA issued a Warning Letter to Cytophil, Inc. following an inspection from January 27 to February 13, 2014, at their East Troy, Wisconsin facility. The firm manufactures synthetic bone graft material, bone void fillers, and an intranasal splint, classified as devices. The inspection revealed these devices to be adulterated because their manufacturing, packing, storage, or installation methods, facilities, or controls did not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations included the failure to adequately establish procedures for controlling environmental conditions (21 CFR 820.70(c)), such as investigating out-of-specification clean room monitoring results and setting temperature/humidity parameters. The firm also failed to adequately validate its sterilization process (21 CFR 820.75(a)), lacking critical parameters like dose mapping and product specifications. Furthermore, Cytophil, Inc. did not adequately establish procedures for changes to specifications (21 CFR 820.70(b)), making changes without verification or validation. Deficiencies were also noted in their corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)), including inadequate investigations and failure to verify corrective action effectiveness. Lastly, the firm lacked adequate process control procedures (21 CFR 820.70(a)) for in-process product temperature and testing, and failed to establish procedures for controlling storage area temperatures (21 CFR 820.150) for sensitive finished devices.

The FDA acknowledged the firm's March 6, 2014 response but stated that corrective actions require verification during a subsequent inspection. Cytophil, Inc. must take prompt action to correct these violations within 15 business days, providing documentation and a timetable. Failure to comply could lead to regulatory actions such as seizure, injunction, civil money penalties, impact on federal contracts, and denial of premarket approvals or Certificates to Foreign Governments. The letter emphasized that these violations might indicate systemic quality management issues requiring thorough investigation.