Drugs

Ideal Pharmacy Inspection Observations

FDA has released the FDA-483 issued following a 9/13-11/18/21 inspection at Ideal Pharmacy, a Union, NJ, compounding pharmacy. The seven inspection observations were:

ISO-5 classified areas were not certified under dynamic conditions;
media fills were not performed that closely simulate aseptic compounding operations incorporating, as appropriate, worst-case activities and conditions that provide a challenge to aseptic operations;
the ISO-5 classified area is located within a non-classified room (segregated compounding area);
the final containers/closures used for drug products intended to be sterile were not maintained to ensure that drug products intended to be sterile maintain sterility;
non-microbial contamination was observed in the compounding area;
vermin was observed in areas immediately adjacent to the compounding area; and
Ideal compounded drugs while construction was underway in an adjacent area without adequate controls to prevent contamination of the compounding environment and product.

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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