Drugs

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.

BBCOS Cherasco, Italy (11/29/2017): FDA inspected the firm 6/2017 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. It also failed to ensure the identity of components sourced from various suppliers, including your active ingredients.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm592712.htm

Beauty Manufacturing Solutions Coppell, TX (1/12): FDA inspected the firm 6/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. In addition, the firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm592684.htm

BioModeling Solutions Beaverton, OR (1/12): FDA inspected the firm 9/2017 an cited GMP deviations associated with the manufacturing of dental medical devices. For example, the firm failed to establish procedures for design controls. The firm also failed to establish and maintain procedures for corrective and preventive actions.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm592704.htm

Wong Lap Kwong Medicine Co. Hong Kong, China (1/11): FDA inspected the firm 9/2017 and cited significant GMP violations for finished pharmaceuticals. The firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit. The firm also failed to ensure the identity of components, including your active ingredients and excipients from various suppliers.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm592846.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