FDA Policy/General

Latest FDA Warning Letters

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

Boule Medical Stockholm, Sweden (10/2): FDA inspected the firm and cited GMP deficiencies with its Medonic M-Series Hematology Analyzer. For example, the firm failed to establish and maintain adequate procedures for implementing corrective and preventive actions. It also failed to establish and maintain adequate procedures for receiving, reviewing and evaluating complaints by a formally designated unit.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm624323.htm

Cardiomed Supplies, Lindsay, Canada (9/21): FDA inspected the firm in May and cited GMP deficiencies with its Phlebotomy Bag with Valve and Dual Floating Dialysis Catheter/Tray. For example, the firm failed to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process be validated. It also failed to establish and maintain procedures for implementing corrective and preventive actions.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm624407.htm

Gaeltec Devices Dunvegan, United Kingdom (7/2): FDA inspected the firm 12/2017 and cited GMP deviations with its Catheter Tip Pressure Transducers. For example, the firm failed to ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated. Gaeltec also failed to establish and maintain procedures for implementing corrective and preventive actions.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm624321.htm

Leventon Barcelona, Spain (9/5): FDA inspected the firm in March and cited GMP deviations with its Dosi Flow elastomeric infusion pump and Dosi Flow administrative set. For example, the firm failed to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated. It also failed to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm624339.htm

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome