FDA Warns South Korea Device Manufacturer for Failure to Correct Faulty Syringes
The Food and Drug Administration sent a warning letter March 15 to South Korean device manufacturer Feel-Tech, alleging violations of current good manufacturing practices at the company’s Cheonan-si facility. Among the violations were insufficient corrective action plans to prevent recurrence…
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of needles dislodging from its syringe barrels. The syringes had been the subject of two separate recalls due to the problem. FDA ordered the company to respond within 15 days of receipt of the letter, warning that premarket approval applications from the company may be denied until the violations are corrected.