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.

American Contract Systems Bloomington, MN (11/6): FDA inspected the firm’s medical device operations in October and cited GMP deficiencies. For example, the firm failed to adequately validate a process whose results cannot be fully verified by subsequent inspection and test. American Contract also failed to establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm625770.htm

Product Packaging West North Hollywood, CA (11/2): FDA inspected the firm in March and cited GMP violations for finished pharmaceuticals. For example, the firm failed to conduct at least one test to verify the identity of each component of a drug product. Additionally, the firm failed to establish written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm625806.htm

Surmasis Pharmaceutical Des Moines, IA (11/6): FDA inspected the firm in February and cited GMP deficiencies for finished pharmaceuticals. For example, the firm’s quality control unit failed to review and approve all drug product production and control records to determine compliance with all established, approved written procedures before a batch is released or distributed. The firm also failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced.

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm625815.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