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# Expert Compounding Pharmacy FDA-483
- URL: https://www.fdaweb.com/expert-compounding-pharmacy-fda-483/
- Published: 2022-06-28T12:00:00.000Z
- Updated: 2026-09-14T17:50:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152186

FDA has released the FDA-483 issued following a 2/23-3/4 inspection at Expert Compounding Pharmacy, a Lake Balboa, CA, producer of non-sterile drugs. The six [inspection observations](https://www.fda.gov/media/159423/download?ref=fdaweb.com) were:

- producing hazardous drugs without providing adequate cleaning of utensils to prevent cross-contamination;
- non-microbial contamination was observed in the production area;
- using a non-pharmaceutical grade component in the formulation of a drug product;
- testing and release of drug products for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient before release;
- laboratory controls do not include determination of conformance to appropriate written specifications for the acceptance of each lot within each shipment of components used in the manufacture, processing, packing, or holding of drug products; and
- batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing and processing.