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# 5 Observations on BSO FDA-483
- URL: https://www.fdaweb.com/5-observations-on-bso-fda-483/
- Published: 2024-10-03T12:00:00.000Z
- Updated: 2026-09-14T14:43:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157912

FDA has released the form FDA-483 issued following a 6/25-7/3 inspection at the BSO outsourcing facility in Lakewood, CO. The five inspection observations were:

- failure of procedures designed to prevent microbiological contamination of drug products purporting to be sterile to include adequate validation of the sterilization process;
- employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions;
- failure to establish time limits, when appropriate, for the completion of each production phase to assure the quality of the drug product;
- failure to thoroughly review any unexplained discrepancy, whether or not the batch has been already distributed; and
- failure to follow the written stability testing program.