FDA Warning Letters

摘要

Device labeler, packer and distributor of Biomedics, Proclear, Frequency, Biofinity, Avaira and Hydron contact lenses cited for QS reg violations. Process validation activities weren't conducted; for example, the firm didn't check to ensure that labels on contact lens packages matched labels on the box in which they were shipped. Procedures were not established for acceptance activities. Further, device history records were not established. Corrective and preventive action procedures were not established and maintained; for example, the company did not initiate a CAPA when it was made aware that shipping box labels did not match contact lens labels. Complaints involving mislabeling also were not investigated. [Issued by New York District Office]