Drugs

10 Observations on Fujifilm Diosynth FDA-483

FDA has released the FDA-483 with 10 observations issued following a 4/14-4/21 inspection at Fujifilm Diosynth Biotechnologies USA, a Morrisville, NC, drug substance manufacturer. The observations were:

there are no comprehensive risk assessments conducted at this multi-product facility to justify the containment strategy and controls of manufacturing redacted products using microbial and cell culture processes to prevent cross-contamination;
a redacted manufacturing process is not adequately monitored and/or controlled to ensure the quality of a drug substance is not adversely affected;
procedures of material management systems are not followed or are inadequate;
failing to establish adequate cleaning and sanitization procedures for non-dedicated product contact equipment at the multi-product manufacturing facility to prevent cross-contamination;
discrepancies are not fully investigated to identify a root cause and corrective and preventive activities are not adequately implemented to prevent a recurrence;
microbial control of the facility is inadequate;
a redacted microbial hold time study was not adequately conducted;
written procedures are not followed by manufacturing employees;
failing to establish procedural controls for electronic data acquisition systems to ensure that data records are protected from unauthorized manipulation; and
manufacturing areas and equipment in the facility are not adequately designed, maintained, and labeled.

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