> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# 15 Observations in Jubilant HollisterStier FDA-483
- URL: https://www.fdaweb.com/15-observations-in-jubilant-hollisterstier-fda-483/
- Published: 2025-07-31T12:00:00.000Z
- Updated: 2026-09-14T15:18:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159606

FDA has released the form FDA-483 issued following a 6/3-6/14/2024 inspection at the Jubilant HollistierStier General Partnership drug manufacturing facility in Kirkland, Province Quebec, Canada. The 15 inspection observations were:

- failure of the statistical quality control criteria to include appropriate acceptance and rejection levels;
- failure to thoroughly review any unexplained discrepancy or 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;
- separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the aseptic processing of drug products;
- failure of procedures designed to prevent microbiological contamination of drug products purporting to be sterile to include adequate validation of the aseptic process;
- failure to test through appropriate laboratory testing each batch of product required to be free of objectionable microorganisms;
- failure of laboratory controls to include the establishment of scientifically sound and appropriate test procedures designed to assure that in-process materials conform to appropriate standards of quality and purity;
- failure to test through appropriate laboratory testing each batch of drug product required to be free of objectionable microorganisms;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- failure of written procedures describing the handling of complaints to include provisions for review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications and a determination as to the need for an investigation of any unexplained discrepancy;
- failure of batch production and control records to include complete information relating to the production and control of each batch;
- failure of written procedures for cleaning and maintenance to include parameters relevant to the operation;
- aseptic processing areas are deficient in the system for cleaning and disinfecting the equipment to produce aseptic conditions;
- failure to subject to microbiological tasks before use each lot of a compound that is liable to microbiological contamination that is objectionable;
- failure to have written procedures describing the calibration of instruments, apparatus, gauges, and recording devices; and
- failure to examine visually at least once a year for evidence of deterioration the reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures.