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# Advanced Pharma Inspection Report
- URL: https://www.fdaweb.com/advanced-pharma-inspection-report/
- Published: 2016-08-11T12:00:00.000Z
- Updated: 2026-09-14T21:23:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136481

FDA has released the FDA-483 issued at the end of a 7/11-7/22 inspection at Advanced Pharma, Houston, TX. Specific inspection [observations](http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm516115.pdf?ref=fdaweb.com) included: 

- failing to establish procedures to prevent microbiological contamination of drug products purporting to be sterile;
- failing to have written test procedures relative to appropriate laboratory testing for sterility and pyrogens;
- failing to include in testing and release of drug product for distribution appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release;
- failing to have or follow written procedures describing the calibration of instruments, apparatus, gauges, and recording devices; and
- failing to have complete labels for the outsourcing facility’s drug products.