FDA 483 - Techni Med, Inc. dba The Compounder - July 09, 2015

This FDA Form 483 details multiple deficiencies observed during an inspection of a facility producing sterile drug products.

**Environmental Control & Aseptic Processing:** * The environmental monitoring program is inadequate, lacking viable/non-viable monitoring inside ISO5 laminar flow hoods or adjacent ISO7 clean rooms during aseptic operations. * Personnel monitoring (gloves, forearms, chest) is not performed during aseptic processing. * No microbiological media test method is established to ensure disinfectant efficacy for microorganism recovery. * Personnel were observed wearing non-sterile gowning during aseptic processing in an ISO5 laminar flow hood (e.g., compounding Baclofen 1000mcg/ml Inj. Lot 05072015@588#5). * Aseptic processing validation is deficient; media fill studies do not simulate complex conditions, and sterilization processes for products like Progesterone (17-A Hydroxy) Caproate 250mg/ml Inj and Estradiol Valerate in Cottonseed Oil 40mg/ml Inj are not validated. * Dynamic smoke studies are not performed in ISO5 laminar flow hoods to ensure proper air patterns. * Equipment qualification studies for sterilization equipment are not performed. * HEPA filter replacement frequency procedures are not established, and filters in ISO5 laminar flow hoods have not been changed since 2005 and 20