Techni Med, Inc. dba The Compounder – FDA 483, Jan 26, 2018

From January 8-26, 2018, the FDA inspected Techni Med, Inc. dba The Compounder, a producer of sterile and non-sterile drug products in Aurora, IL. The inspection revealed multiple violations related to sterile drug production, quality control, and documentation.

**Key Observations:**

* **Sterile Product Contamination Prevention (Observation 1):** * Personnel gloved bare hands inside the ISO-5 area during aseptic processing. * Inadequately protected sterile product was exposed to air quality lower than ISO 5. * ISO 5 areas were not certified under representative dynamic conditions; smoke studies did not reflect actual aseptic processing. * Media fills did not simulate worst-case aseptic production activities. * Environmental monitoring was not performed in all aseptic processing areas (e.g., pass-throughs) and was not conducted during every drug production shift in the ISO-5 area. * Pressure differentials between classified areas were not continuously monitored. * Finished products, including 1 ML 31G 5/16IN TRIMIX SYRINGE and THIAMINE INJECTION 30 ML, were distributed without patient-specific prescriptions and lacked testing for objectionable microorganisms.

* **Product Testing and Release (Observation 2):** * Intrathecal products (e.g., Hydromorphine