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# 9 Observations in Staska Pharmaceuticals FDA-483
- URL: https://www.fdaweb.com/9-observations-in-staska-pharmaceuticals-fda-483/
- Published: 2024-11-06T12:00:00.000Z
- Updated: 2026-09-14T14:46:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158131

FDA has released the form FDA-483 issued following a 9/3-9/18 inspection at the Staska Pharmaceuticals outsourcing facility in Bennet, NE. The nine 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 to establish acceptance criteria for the sampling and testing conducted by the quality control unit that are adequate to assure that batches of drug products meet each appropriate specification and appropriate statistical quality control criteria as a condition for their approval and release;
- employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
- failure to establish written procedures for production and process controls designed to assure that drug products have the identity, strength, purity, and quality they are purported or represented to possess;
- failure to establish and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile,
- containers of the facility’s drug products do not include information required by law; and
- bulk drug substances used by the facility to compound drugs are not manufactured by an establishment that is registered with FDA as required by law.