CoRE labs, LLC – FDA Warning Letter, Jul 25, 2012

This FDA Warning Letter, Ref: # DEN-13-07-WL, was issued to CoRE Labs, LLC following a July 2012 inspection of their Englewood, CO facility, which manufactures Flora Wall Bucky Stands and Atlas Radiographic Tables. The inspection identified significant violations of the Federal Food, Drug, and Cosmetic Act, including non-compliance with Electronic Product Radiation Control standards (21 U.S.C. § 360oo(a)) and misbranding (21 U.S.C. § 352(t)(2)), alongside extensive Quality System deficiencies (21 CFR Part 820).

Key violations included failure to maintain radiation safety test records (21 CFR 1002.30(a)(2)), provide product certification (21 CFR 1010.2(a)), and submit abbreviated reports (21 CFR 1002.12). The firm also failed to adequately develop and implement written Medical Device Reporting (MDR) procedures (21 CFR 803.17), lacking proper event identification, review, transmission, and record-keeping.

Numerous Quality System deficiencies were cited across various areas, including acceptance activities, production process control, nonconforming product, Device Master Records, process validation, purchasing, design changes, Device History Records, complaint handling, equipment calibration/maintenance, quality audits, management review, training, and document control (21 CFR Part 820).

CoRE Labs must promptly correct all violations and provide a written response within fifteen business days detailing corrective actions, documentation, and a timetable. Failure to comply could lead to regulatory actions like seizure, injunction, civil money penalties, and impact on federal contracts and device approvals. The firm's initial response to the FDA-483 was deemed unsatisfactory.