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.

Hanbul Cosmetics Co. Republic of Korea (3/29): FDA inspected the firm 11/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm could not provide raw data to verify that it performed microbiological finished product testing for over-the-counter (OTC) drug products. Additionally, stability studies were found to be inadequate to ensure the OTC drug products remain within specification throughout their labeled expiry period.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm604272.htm

Luen Wah (HK) Medicine Hong Kong (4/6): FDA inspected the firm 9/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm released over-the-counter (OTC) drug products to the U.S. without testing the identity and strength of each active ingredient. Additionally, the firm failed to test incoming active pharmaceutical ingredients and other components used to manufacture OTC drug products to determine their identity, purity, strength, and other appropriate quality attributes.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm604456.htm

SynCardia Systems Tucson, AZ (4/3): FDA inspected the firm 8/2017 and cited it for Medical Device Reporting (XXX DELETE – NOT USED AGAIN XXX) violations for its SynCardia Temporary Total Artificial Heart (TAH-t) System. For example, the firm failed to timely report a device incident that may have caused a death. Additionally, the firm failed to adequately develop, maintain and implement written MDR procedures.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm604278.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