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# 4 Observations on Imprimis FDA-483
- URL: https://www.fdaweb.com/4-observations-on-imprimis-fda-483/
- Published: 2024-08-08T12:00:00.000Z
- Updated: 2026-09-14T14:37:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157529

FDA has released the form FDA-483 issued following a 3/11-4/3 inspection at Imprimis NJOF, LLC, a Ledgewood, NJ, outsourcing facility. The inspection observations were:

- failure to reject drug products failing to meet established specifications;
- failure to thoroughly review any unexplained discrepancy, the failure of a batch or any of its components to meet any of its specifications, whether or not the batch has been already distributed;
- failure to establish and follow procedures to prevent microbiological contamination of drug products purporting to be sterile; and
- failure of laboratory controls to include the establishment of scientifically sound and appropriate specifications and test procedures to assure that drug products conform to appropriate standards of identity, strength, quality, and purity.