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.

Centurion Laboratories Private Gujarat India (4/5): FDA inspected the firm 10/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards. The firm also failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records. Additionally, Centurion failed to follow written procedures for cleaning and maintenance of equipment. To view the letter, click here.

Orchid Orthopedic Solutions, Holt, MI (5/13): FDA inspected the firm 2/4-15 and cited it for significant GMP violations for its medical devices. For example, Orchid failed to establish and maintain procedures to control product that does not conform to specified requirements. It also failed to establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that specified requirements continue to be met. Additionally, the company failed to establish and maintain procedures for implementing corrective and preventative actions. To view the letter, click here.

Rechargeable Power Energy North America Las Vegas, NV (5/9): FDA inspected the firm 11/2018 and cited Quality System Regulation violation with its Automated External Defibrillator (AED) Battery, which is intended to replace the original battery used in an undisclosed automated external defibrillator. For example, the firm failed to validate with a high degree of assurance a process whose results cannot be fully verified by subsequent inspection and test. It also was unable to demonstrate that the process used for finished product functional testing of the batteries has been validated. And, the company failed to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. To view the notice, click here.

Zeller Power Products Wallace, ID (5/9): FDA inspected the firm 11/2018 and cited it for Quality System Regulation violations with its Automated External Defibrillator (AED) Battery intended to replace the original battery used in Cardiac Science’s PowerHeart AED G3 automated external defibrillators. For example, the firm failed to validate the device’s design. Zeller also failed to establish procedures for design controls. And, it failed to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. To view the letter, click here.

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

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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