FDA / Regulatory News
FDA Warning Letters
An FDA warning letter is a formal notification from the FDA that identifies serious regulatory violations. A warning letter is issued by senior FDA officials after they’ve reviewed the inspector’s report. A warning letter is considered an escalation from an observation.
The most common causes for an FDA warning letters are:
- Non-compliant written procedures.
- Failure to follow written procedures.
- Failure to prove that regulations have been followed with adequate documentation.
Latest FDA warning letter, posted Feb 4, 2020
Company Name – Won Industry Co. LTD (South Korea, manufacturer of Morning Life Compression Limb Therapy System)
Subject: CGMP/QSR/Medical Devices/Adulterated
Violations included in the letter:
- Failure to adequately establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).
- Failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
- Failure to adequately establish and maintain procedures to ensure that device history records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record (DMR) and the requirements of this part, as required by 21 CFR 820.184.
Product Recalls and Issues
Abbott Vascular Coronary Catheters
Class 1 recall
Abbott is recalling the coronary catheters because the balloons may fail to deflate as intended. That’s because of potentially weaker material near the balloon bond caused by excessive exposure to heat during manufacturing. Abbott received 13 complaints about the catheters, and one death was reported.
ResMed Ventilators
Class 1 recall
ResMed is recalling its Stellar 100 and 150 non-invasive and invasive ventilators because the sound alarm may fail to work if the device has a failed electronic part, is stored without AC power connected for more than 36 hours (letting the battery drain completely), and the device powers on automatically when connected to AC power without the power switch being pressed. One death was reported.
Teleflex Humidification Systems
Class 1 recall
The Comfort Flo Humidification systems are being recalled because water could enter the circuit in the system and reach the patient’s nose and lungs, potentially causing serious health issues such as low oxygen in the blood or the need for treatment to prevent injury.
There were 102 complaints and eight injuries related to the device, including low blood oxygen and slower than normal heart rate.
