FDA 483 - Techni Med, Inc. dba The Compounder - October 10, 2019

Techni Med, Inc. dba The Compounder in Aurora, IL, was inspected by the FDA, revealing significant deficiencies in sterile and non-sterile drug product manufacturing. Observations included non-microbial and microbial contamination in cleanroom areas, inadequate product testing for pyrogen-free requirements, and the use of non-pharmaceutical grade components and non-sterile cleaning wipes. These issues indicate a lack of control over environmental conditions and product quality.