Drugs

Sato Pharmaceutical FDA-483 Out

FDA has released the form FDA-483 issued following an 11/13-11/21/2025 inspection at the Sato Pharmaceutical over-the-counter sterile and non-sterile drug manufacturing facility in Hachioji, Tokyo, Japan. The 10 specific inspection observations were:

failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
failure of procedures designed to prevent any microbiological contamination of drug products purporting to be sterile to include adequate validation of the aseptic process;
failure to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods;
the quality control unit lacks the responsibility and authority to approve and reject all drug products;
failure to follow the written stability testing program;
failure of the written stability program for drug products to include specific test methods;
failure of laboratory controls to include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity;
aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
failure to clean, maintain, and sanitize equipment and utensils at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality, or purity of the drug product; and
failure to wear protective apparel as necessary to protect drug products from contamination.

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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