FDA Policy/General

Latest FDA Warning Letters

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

Indoco Remedies Ltd. Verna, Goa, India (3/27): FDA inspected the firm’s drug manufacturing facility 9/2016 and cited GMP violations related to its finished pharmaceuticals. For example, the firm failed to establish and follow adequate written procedures describing the handling of all written and oral complaints regarding a drug product. The firm also failed to ensure that the responsibilities and procedures applicable to its quality control unit were followed. Additionally, FDA noted that it had cited Indoco Remedies for similar violations during a 2011 inspection, and it recommended that the firm retain a GMP consultant to assist it in meeting GMP requirements.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm550321.htm

Mylan Pharmaceuticals Canonsburg, PA (4/3): FDA inspected the firm’s Maharashtra, India facility 9/2016 and cited significant GMP violations involving finished pharmaceuticals. For example, Mylan failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. Also, it failed to establish an adequate quality control unit with the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they were fully investigated. Additionally, FDA said the firm’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures. It acknowledged that Mylan is using a consultant to audit its operations and assist in meeting FDA requirements.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm550326.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