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.

CFP Acquisitions, Inc. (dba The Apothecary Shoppe) Broken Arrow, OK (8/19). FDA inspected pharmacy compounding operations in March and noted that the firm was not receiving valid prescriptions for individually-identified patients for a portion of the drug products it was producing. The investigators also found that the firm produces domperidone products, which do not have official monographs. Furthermore, FDA investigators observed that the firm produced a drug product (potassium chloride) that appears on the agency’s list of drugs that have been withdrawn or removed from the market because they have been found to be unsafe or not effective.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm524082.htm

Delarange Cosmetics & Healthcare BV Zeewolde, The Netherlands (9/29). FDA inspection in June documented GMP violations involving finished pharmaceuticals. The firm’s Form 483 response indicates it no longer will produce products for the U.S. market, and therefore it declined to address any of the violations.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm524124.htm

Laboratoire Sintyl S.A. Geneva, Switzerland (9/29). FDA inspected the firm in June and documented GMP violations. The firm indicated in its Form 483 response that it no longer was manufacturing over-the-counter drug products for the U.S. market.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm524002.htm

Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd. Yangzhou, Jiangsu, China (9/26). FDA inspected the firm in January and documented serious GMP violations. The firm failed to provide adequate written production and control procedures. Samples collected at port of entry found the products did not contain any of the labeled active ingredient. The firm also does not have appropriate laboratory analyses to determine products conform to final specifications. FDA placed the firm and its products on import alert in August.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm524001.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