FDA Policy/General

Latest FDA Warning Letters

Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

Huron Pharmaceuticals, Farmington Hills, MI (4/20): FDA inspected the firm 12/2016 and cited significant GMP deviations for active pharmaceutical ingredients (API). For example, the firm repeatedly omitted the name and address of the original API manufacturer on certificates of analysis issued to customers and did not include a copy of the original batch certificate. Additionally, it had no written procedures for supplier qualification, relabeling and repackaging operations, sampling, product release, stability, and document retention.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm556148.htm

Lonza Group Ltd., Basel, Switzerland (4/21): FDA inspected the firm’s Walkersville, MD facility in February and cited GMP deviations related to Class 2 undisclosed medical devices. For example, Lonza was cited for an inadequate validation master plan for cleaning validations, clean room qualifications, and HEPA filter certifications. The inspection also cited the firm’s media production due to having no predefined acceptance criteria or monitoring for viable organisms.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm556170.htm

Rainbow Gold Products, Sardis City, AL (5/4): FDA inspected the firm’s drug repackaging and relabeling facility August 2016 and determined that its Vopac MDS Anti-Inflammatory Management Kit with Metered Dose Spray System includes an unapproved new drug, and that Isometheptene-Dichloral-APAP and Vayarin are unapproved new drugs. The agency said Vopac was labeled for treating signs and symptoms of osteoarthritis of the knee, and Isometheptene-Dichloral-APAP was labeled for relieving tension and vascular headaches.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm556884.htm

Vikshara Trading & Investments Ltd., Gujarat, India (4/28): FDA inspected the facility 10/2016 and the firm delayed and limited the inspection. The letter cites significant GMP violations involving finished pharmaceuticals. The firm did not provide batch records to the FDA investigator, but promised to send them electronically, but they were never received. During the inspection, the lights were off in the facility and the investigator had to use a flashlight. Even with limited visibility, the investigator observed undisclosed powder scattered throughout the production areas. FDA placed the firm on Import Alert 66-40 on 2/8.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm556425.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