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.

Emcure Pharmaceuticals, Maharashtra, India (8/2): FDA inspected the firm in February 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. FDA said that the company’s review of environmental data was insufficient in that it relied too heavily on findings in the laboratory. It also concluded that data indicated potential contamination control risks in the testing facility, but did not sufficiently address production failure modes. To view the letter, click here.

Lantech Pharmaceuticals, Hyderabad, India (8/8): FDA inspected the drug manufacturing facility in March and cited significant GMP deviations for active pharmaceutical ingredients (APIs). For example, the company’s quality unit failed to ensure that quality-related complaints are investigated and resolved. FDA noted that the firm manufactures angiotensin II receptor blockers (ARBs) including valsartan, telmisartan, and olmesartan API and intermediates for non-U.S. supply chains. It failed to adequately evaluate the potential of these ARBs to form nitrosamines and identify potential cross contamination risks for drugs made using non-dedicated equipment and shipped into the U.S. supply chain. To view the letter, click here.

Spectrum Laboratory Products, Gardena, CA (7/31): FDA inspected the firm in March and cited significant GMP deviations for active pharmaceutical ingredients (API). For example, the firm failed to transfer all API quality or regulatory information to its customers. FDA said it recently cited similar violations at a separate facility within the company’s network, and it suggested that a GMP consultant be retained to assist in meeting requirements. To view the letter, click here.

Talon, Houston, TX (8/2): FDA inspected the firm in March and cited it for manufacturing devices that do not conform with GMP requirements of the quality system regulation. For example, the company failed to document corrective and preventive action activities. Talon also was cited for failing to establish procedures for design change, and to control products that do not conform to specified requirements. Additionally, it failed to document acceptance or rejection of incoming products. 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

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