Puhiic Heaiih Sen/toe road and Drup Administration Kansas Clty Dislnci Soumwul n-elan soso Mil on", Sun- ms Lanm, Kansas ssziuszt rolepnone. (S13)t95<<5100 February 26, 20M Kimberiy A. Grinston, JD Executive Director Missouri Board of Pharmacy 3605 Missouri Boulevard P.0, Box 625 Jefferson City, MO 65102-0625 Dear Ms. Grinston: The purpose oithis letter IS to refer to the Missouri Board or Pharmacy ieor) for appropriate follow-up the US, Food and Drug Administration's (FDA) concerns about poor steriie practices observed durln an FDAins 2: on at a harmac licensed the Missouri BOP, Foundation Care, FDA inspected the firm from March 11, 2013 to March 19, 2013, investigators were accompanied by a Missouri State SOP inspector for two days of the Inspection Attached is a redacted copy of a Form FDA 483 that documents our investigators' observations irom the inspection. During the inspection, the FDA investigators reviewed a 5m ali sample oi records for products compounded by Foundation Care and determined, based on this sample, that this firm appears to obtain valid prescriptions ror indivxduaiiyridentified patients forthe drug products that it compounds and dispenses In the April 9, 2013 response to the Form FDA 483, the firm advised FDA that "Ail compounded products are prescribed by a phySician and dispensed directiv to our patients. Foundation Care does not compound drugs for office use," During the inspection, the FDA investigators observed deviations from appropriate steriie practice standards that, if not corrected, could lead to contamination or drugs, potentially putting patients at risk. Exampies of deviations observed during our inspection include: 1. The rirrn's viable and non-viabie environmental monitoring program ensuring microbioiogical quality of the ISO 5 and 7 areas is inadequate For example, the iirm's environmental monitoring program does not inciude critical manuiacturing equipment located in the iso 5 area, nordoes it specifythe required frequency orsampiing, orwhen See attached response letter dated April9,20131rom Daniel Biakeiy, man to Kansas city Districl Investigators. samples are to be collected based on related activity in the compounding areas. in addition, the firm's program lacks scientifically based justification for the sample locations In its response, the firm committed to revise its viable and non-viable environmental monitoring program to include all equipment contained in the cleanroo However, in the revision the firm also changed their program testing requirement iron-tom We recommend that the environmental monitoring program be audited as part oithe state's follow up activities including the adequacy of the frequency and time of sampling and evaluation of sample locations 2 The firm does not conduct adequate qualification studies to assess whether proper particle control dynamics have been achieved throughout the ISO 5 area For example, the lirm has not Conducted smoke studies since 2012, 3. The firm failed to record supplier lot numbers of TPN bags and ampules used in compounding of sterile drugs. 4 The investigator observed employee's using glassware tor product waste and cleaning and then placing the glassware on tables where sterile compounding activities occur prior to cleaning the glassware adequately. Foundation Care committed to FDA 'in its April 9, 2013 response to the Form FDA 483 to correct some olthe deViations After review olthe record, at this time FDA does not intend to take further action with regard to the iindings of this inspection. This apparently obtains prescriptions for identified individual patients, consistent with traditional pharmacy practice. In addition, the deviations identified appearto be readily correctable, and the firm has agreed in writing to correct some ofthe deviations Therefore, FDA believes that the corrective actions can be appropriately overseen by the State, and is reiernng this matter to the Missouri State eon tor followup to ensure appropriate corrective action is taken. Please notify us if you become aware of any adverse events or product quality concerns associated with drugs made at this lacilityy or it you observe any practices at this facility that concern you or that could be violations of Federal law, We look lorward to continuing to work With you on the overSight of compounding pharmacies. ll tional questions lease Contact Denial S. Hutchison, Compliance officer, at by emsi Sincerely, Au Ylw' David Miser Acting District Director Kansas City District Office