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Talk to a SpecialistTalk to a SpecialistPharmacy Plus, Inc., dba Vital Care Compounder was cited for producing sterile drug products under insanitary conditions that violated current good manufacturing practices (CGMP) and rendered the products adulterated under the Food, Drug, and Cosmetic Act. FDA inspectors identified serious deficiencies including failure to take appropriate corrective action after microbial contamination was detected in the ISO 5 aseptic processing area. The company had already initiated a recall of sterile products within their expiration date in October 2022 due to lack of sterility assurance, acknowledging the contamination risks to patients.