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

An FDA Form 483 was issued following an inspection that identified two observations related to contamination control and environmental monitoring.

Observation 1 details non-microbial contamination in the production area. On September 23, 2019, black residue was observed on two white plastic garbage cans, one located in the ISO 7 cleanroom and another in the ISO 8 anteroom. Additionally, black residue was noted on the far corner of the ISO 7 cleanroom floor.

Observation 2 addresses inadequate product evaluation and remedial action concerning actionable microbial contamination adjacent to the ISO 5 aseptic processing area during production. On May 23, 2018, a cleanroom certification revealed out-of-specification results for viable monitoring in one ISO 8 location and four ISO 7 locations. Despite routine cleaning and environmental monitoring resuming, a follow-up cleanroom certification was not conducted until September 12, 2018. Sterile processing continued routinely between May 23, 2018, and September 12, 2018.