Joe Wise Pharmacy, Inc., dba Wise Pharmacy — FDA Warning Letter Findings

The non-classified room in which your ISO 5 workstation is operated contains a sink and dishwasher, both of which are potential sources of microbial contamination.

Your practices for cleaning are deficient in that your (b)(4) hoods, in which both hazardous and non-hazardous bulk drugs are handled, is cleaned with only (b)(4) . Consequently, hazardous drugs are not adequately deactivated, posing a contamination risk to non-hazardous drug products, as well as other hazardous drug products.

Your firm failed to confirm that the quality of water was suitable for its intended use in the production of non-sterile drug products.

Your routine environmental monitoring (EM) is inadequate in that EM samples collected from the ISO 5 surface are “incubated” at uncontrolled room temperature on a counter in the non-classified compounding room. It is a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated. C. Corrective…

Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.