USFDA issues warning letter to two sterile Drug compounders
US FDA has recently issued warning letter to Florida based absolute pharmacy and Van Healthcare Services. Florida based Absolute Pharmacy is registered as an outsourcing facility with USFDA since 2013 while Vann Healthcare Services is a non registered compounder. Under the section 501(a) (2) (B) of the FDCA outsourcing facilities must comply with the CGMP requirements.
But during the inspection, investigator noted that the drug products that were intended or expected to be sterile were prepared, packed, or held under insanitary conditions. Also the Pharmacy fails to establish an adequate system for monitoring environmental conditions in aseptic processing areas. To clean and sterile containers to remove pyrogenic properties, and failing to establish an adequate air supply filtered through high efficiency particulate air filters.
Additionally, In Van Healthcare Services the agency noted failures in following written protocol to prevent microbiological contamination of sterile drug products, failures to ensure that manufacturing personnel wear clothing appropriate to avoid contamination, and issues with cleaning and disinfecting the aseptic equipment. Van Healthcare Services has issued a voluntary recall of all the sterile products and informed FDA.