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# 3 Inspection Observations in KRS FDA-483
- URL: https://www.fdaweb.com/3-inspection-observations-in-krs-fda-483/
- Published: 2018-01-03T12:00:00.000Z
- Updated: 2026-09-14T23:10:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140409

FDA has released the FDA-483 issued following a 10/16-10/23/17 inspection at KRS Global Biotechnology, Boca Raton, FL, an outsourcing facility. The [observations](https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm590824.pdf?ref=fdaweb.com) were: 

- 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;
- there is a 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; and
- each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.