Latest FDA Warning Letter

FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below:

Vital Rx dba Atlantic Pharmacy and Compounding Pompano Beach, FL (9/26): FDA inspected the firm in July and cited serious deficiencies with its practices for producing drug products. For example, the firm did not use a sporicidal agent to disinfect the laminar flow hood, an area where drug products intended to be sterile were produced. The firm also had no assurance that the endotoxin level of its intrathecal drug products is safe since it did not have any endotoxin data and it doesn’t perform endotoxin testing. Additionally, the firm was found using non-pharmaceutical grade filters to sterilize drug products, and it has no assurance that glass vials used for filling injectable drug products are sterile.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm624489.htm