Drugs

10 Observations on First Pharma FDA-483

FDA has released the FDA-483 issued following a 5/31 and 6/3-6/7 inspection at First Pharma Associates, Spokane, WA, a producer of sterile and non-sterile drug products. The 10 inspection observations were:

non-microbial contamination was observed in the production area;
personnel were observed manually contacting the inner surface of the container or closure;
hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination;
ISO-5 classified areas were not certified under dynamic conditions;
personnel were observed conducting aseptic manipulations or placing equipment/supplies in an area that blocked the movement of first pass air around an open unit, whether before or after it is filled with sterile product;
the facility is designed and/or operated in a way that permits poor flow of personnel or materials;
the facility design was observed to allow the influx of lower quality air into a higher classified area;
inadequate pressure differentials between higher quality air rooms and lower quality air rooms were observed;
media fills were not performed that closely simulate aseptic production conditions incorporating, as appropriate, worst-case activities and conditions that provide for a challenge to aseptic operations; and
ISO-classified areas have difficult to clear, particle-generating, or visibly dirty equipment or surfaces.

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