The FDA continues to turn up the heat on compounding pharmacies, issuing two warning letters to compounders in Kentucky and California for serious GMP deficiencies related to sterility.
Tustin, Calif.-based Ionia Pharmacy and Spoonamore Drug Co., which is located in Louisville, Ky., were hit with warnings for deficiencies in producing sterile drug products and putting patients at risk; not receiving valid prescriptions for individually identified patients; misbranded drug products; and poorly written guidelines.
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