Drugs

11 Observations on Hybrid Pharma FDA-483

FDA has released the form FDA-483 issued following a 10/16-11/9/2023 inspection at the Hybrid Pharma outsourcing facility in Deerfield Beach, FL. The 11 inspection observations were:

aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions;
procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the aseptic process;
aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure;
equipment used in the manufacture, processing, packing, or holding of drug products is not of appropriate design to facilitate operations for its cleaning and maintenance;
aseptic processing areas are deficient in that floors, walls, and ceilings are not smooth and/or hard surfaces that are easily cleanable;
the facility compounds drug products using bulk drug substances that cannot be used in compounding under section 503(B) of the Federal Food, Drug, and Cosmetic Act;
laboratory controls do not 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;
the accuracy, sensitivity, specificity, and reproducibility of test methods have not been established and documented;
testing and release of drug products for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient before release;
the facility has not submitted a report to FDA identifying a product compounded during the previous six months as required by law; and
master production and control records lack complete manufacturing and control instructions, sampling and testing procedures, specifications, special notations, and precautions to be followed.

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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