Drugs

10 Observations in Somerset Therapeutics FDA-483

FDA has released the form FDA-483 issued following a 2/10-2/21/2025 inspection at Somerset Therapeutics Private Limited, a Bengaluru, Karnataka, India, sterile drug manufacturer. The 10 inspection observations were:

failure to submit a Field Alert Report to FDA within three working days of receiving information concerning bacteriological contamination in the distributed drug product;
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 had already been distributed;
failure of procedures designed to prevent microbiological contamination of drug products purporting to be sterile to include validation of the aseptic process;
failure to establish and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions;
aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
failure of batch production and control records to include complete information relating to the production and control of each batch;
failure of laboratory controls to include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality, and purity; and
failure of laboratory records to include complete data derived from all tests, examinations and assay necessary to ensure compliance with established specifications and standards.

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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