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.

Europharma Concepts Clara Tullamore, Ireland (5/16): FDA inspected the firm 11/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to test samples of each component for conformity with all appropriate written specifications. The firm also failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess. Additionally, FDA recommended that the firm retain a consultant to assist it in meeting CGMP requirements.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm607950.htm

Jalco Cosmetics Silverwater, Australia (5/18): FDA inspected the firm 12/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. The firm also failed to test samples of each component for conformity with all appropriate written specifications for identity, purity, strength, and quality. The agency notes that the firm was placed on an import alert in March.https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm608717.htm

Jilin Shulan Synthetic Pharmaceutical Shulan City, China (5/14): FDA inspected the firm 11/2017 and cited significant GMP deviations for active pharmaceutical ingredients. For example, the firm failed to document known deviations and out-of-specification results and conduct a thorough investigation. Additionally, the firm failed to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failure to have adequate controls to prevent data omissions.https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm608713.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

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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