The FDA sent a warning letter to Japanese ophthalmic laser maker Nidek Co. after finding quality control violations during a May inspection of a plant in Aichi, Japan.
The federal watchdog agency issued a Form 483 to Nidek after the inspection, but the company did not respond within the required 15-day window, according to the warning letter. The letter flagged 6 violations found during the inspection held May 20-23.
The violations included failure to establish adequate procedures "to identify existing and potential causes of nonconforming product or other quality problems and to employ appropriate statistical methodology where necessary to detect recurring quality problems," according to the warning letter.
Nidek also failed to "establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria," the FDA wrote. The company failed to maintain required complaint files and complaint review procedures and failed to "control labeling and packaging operations to prevent labeling mixups," according to the letter.
Finally, the FDA cited Nidek for, "Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer’s established quality policy and objectives."
"For example, your firm has yet to establish a management review procedure," according to the letter.
Nidek’s response to the Sept. 24 letter is due today, according to the FDA.