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.

Pocono Coated Products Cherryville, NC (10/27): FDA inspected the firm 10/2015 and documented significant GMP violations related to finished pharmaceuticals. For example, FDA cited the firm for not having an appropriate laboratory determination of satisfactory conformance to final specifications for drug products before releasing them. Samples collected by the agency found sub-potent products. The firm was also cited for failing to validate the manufacturing process for certain transdermal patches. Additionally, the firm was cited for having master batch records that lacked a statement of theoretical yield, percentage of theoretical yield, and statements of limits beyond which an investigation is required.

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm532706.htm

United Contact Lens Arlington, Washington (11/30): FDA inspected the firm 10/4-12 and documented GMP and quality system deviations with its soft contact lens manufacturing (United 55, SonicView, and TreSoft). For example, the firm failed to establish and maintain purchasing control procedures for the evaluation of suppliers, contractors, and consultants. This was a repeat observation from an inspection in 2013. The firm also failed to document Medical Device Report reportability on customer complaint forms as per firm’s procedures. Additionally, the inspection cited the firm’s procedure on calibrating certain equipment because it did not require performance of calibrations using calibration standards that are traceable to national or international standards. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm532322.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