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# Ideal Pharmacy Inspection Observations
- URL: https://www.fdaweb.com/ideal-pharmacy-inspection-observations/
- Published: 2022-01-05T12:00:00.000Z
- Updated: 2026-09-14T17:27:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150866

FDA has released the FDA-483 issued following a 9/13-11/18/21 inspection at Ideal Pharmacy, a Union, NJ, compounding pharmacy. The seven inspection [observations](https://www.fda.gov/media/155178/download?ref=fdaweb.com) were: 

- ISO-5 classified areas were not certified under dynamic conditions;
- media fills were not performed that closely simulate aseptic compounding operations incorporating, as appropriate, worst-case activities and conditions that provide a challenge to aseptic operations;
- the ISO-5 classified area is located within a non-classified room (segregated compounding area);
- the final containers/closures used for drug products intended to be sterile were not maintained to ensure that drug products intended to be sterile maintain sterility;
- non-microbial contamination was observed in the compounding area;
- vermin was observed in areas immediately adjacent to the compounding area; and
- Ideal compounded drugs while construction was underway in an adjacent area without adequate controls to prevent contamination of the compounding environment and product.