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# 6 Observations on Right Value FDA-483
- URL: https://www.fdaweb.com/6-observations-on-right-value-fda-483/
- Published: 2026-09-30T21:51:56.000Z
- Updated: 2026-09-30T21:51:56.000Z
- Author: David McFarland
- Tags: Drugs

FDA has released the Form [FDA-483](https://www.fda.gov/media/195071/download?ref=fdaweb.com) issued following an 8/24-9/8 inspection at Right Value Drug Stores, an Irving, TX outsourcing facility. The six inspection observations were:

- failure to follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- failure of laboratory controls to include the establishment of scientifically sound and appropriate specifications designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity;
- failure to fully follow the responsibilities and procedures applicable to the quality control unit;
- failure to thoroughly review any unexplained discrepancy, whether or not the batch has already been distributed;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions; and
- test devices are deficient in that instruments not meeting established specifications are used.