Curexa – East, LLC dba Curexa
FDA issued a warning letter to Curexa – East, LLC dba Curexa (Egg Harbor Township, NJ) following an August–September 2022 inspection that found serious insanitary conditions in the compounding pharmacy's production area, including non-microbial contamination, inadequate cleaning of utensils and equipment used for hazardous drugs, and residue buildup in air-handling equipment directly above production areas. These conditions rendered the firm's compounded drug products adulterated under section 501(a)(2)(A) of the FDCA. FDA found the firm's corrective-action responses to the Form FDA 483 either insufficiently documented or outright deficient, and warned that failure to adequately address violations may result in seizure or injunction.
Required actions (2)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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