FDA 483 - Medical Center Pharmacy, Inc. - April 09, 2020
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
An FDA inspection of Medical Center Pharmacy, Inc. in Cleveland, TN, revealed significant deficiencies in aseptic processing and facility control. Observations included non-microbial and microbial contamination in classified areas, use of non-sterile cleaning agents, and inadequate testing for endotoxins and sterility. The firm also failed to properly segregate hazardous drug production and maintain calibrated equipment, indicating a severe lack of control over sterile drug manufacturing.
ID · b9c856a6-c38a-4ce5-abe1-4655261cf553