Drugs

15 Observations in Advanced Nutriceuticals FDA-483

FDA has released the FDA-483 containing 15 observations issued following a 10/13-10/29 inspection at Advanced Nutriceuticals, an Indianapolis, IN, producer of sterile drug products. The inspection observations were:

performing aseptic processing outside of a certified ISO 5 area;
the ISO classified aseptic processing area was located within a non-classified room;
employees touched equipment and other surface areas outside the ISO 5 area with gloved hands and proceeded to aseptically process drug product without changing or sanitizing gloves;
a sterile technician moved rapidly in the vicinity of open sterile units or instruments;
a sterile technician conducted aseptic manipulation and placed equipment/supplies in an area that blocks the movement of first-pass air around an open unit;
a sterile technican stoppered sterile drug vials;
supplies outside of the ISO 5 cleanroom hood were not disinfected before entering the aseptic processing area;
systems for monitoring processing and environmental conditions in aseptic processing areas were deficient;
the firm exposed stock solutions used in the production of drug products intended to be sterile to worse-than-ISO 5-quality air;
inadequate use of sporicidal agents in the aseptic processing area;
failing to sterilize the final containers/closures used for drug products intended to be sterile;
an employee produced a sterile drug product using expired material;
the ISO-classified aseptic processing areas and surrounding areas had difficult-to-clean and visibly dirty equipment or surfaces;
facility design allowed the influx of poor-quality air into a higher classified area; and
beta-lactam and hazardous drugs were produced without providing adequate containment, segregation, and cleaning of work surfaces, utensils, and personnel to prevent cross-contamination.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome