Drugs

Fusion IV Pharmaceuticals FDA-483

FDA has released the FDA-483 issued following a 12/2-12/20/19 inspection at Fusion IV Pharmaceuticals (Axia Pharmaceutical), a Los Angeles, CA, producer of sterile drug products. The inspection observations were:

failing to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a clean and sanitary condition;
failing to follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
failing 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;
failing to train employees in the particular operation they perform as part of their function, current good manufacturing practices, and written procedures required by current good manufacturing practice regulations;
failing to have laboratory controls include the establishment of scientifically sound and appropriate test procedures designed to assure that [they] conform to appropriate standards of identity, strength, quality, and purity;
the quality control unit lacks authority to fully investigate errors that have occurred;
aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
failing to document in the batch production records examination of packaging and labeling materials for suitability and correctness before packaging operations; and
failing to laboratory test each batch of drug product purporting to be sterile and pyrogen-free to determine conformance to such requirements.

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