FDA WARNING_LETTER - Creation Technologies - March 05, 2020

On June 5, 2020, the FDA issued a Warning Letter to Michael A. Meyer, Operations Leader of a firm in Burnaby, Canada, following an inspection from March 2-5, 2020. The firm manufactures the neoBLUE neonatal phototherapy unit, classified as a device under the Federal Food, Drug, and Cosmetic Act. The inspection revealed the devices are adulterated because manufacturing, packing, storage, or installation methods do not conform to the Quality System regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: Quality data was not analyzed to identify nonconforming product causes, with numerous nonconformances and complaints lacking documented root causes or CAPAs. CAPA records lacked objective evidence of completed corrective actions or effectiveness checks. The firm's response was inadequate as it did not retrospectively assess open CAPAs or ensure organization-wide training. 2. **Failure to establish and maintain procedures for nonconforming product disposition (21 CFR 820.90(b))**: The process did not prevent unacceptable units from being distributed without justification. Examples included defective PCBs shipped to customers and misprogrammed boards returned by customers, with inadequate traceability and disposition records. The firm's response was inadequate as it did not evaluate existing records for other instances of distributed noncon