FDAnews Drug Daily Bulletin
Pharmaceuticals / GMPs

Kentucky, California Compounders Land FDA Warning Letter

Jan. 21, 2016

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.

A MedWatch report described an adverse event associated with drugs prepared by Ionia that prompted an inspection conducted March 3 through March 6, 2015.

FDA inspectors noted that Ionia’s environmental sampling caused a “false impression” of the effectiveness of the company’s cleaning and sanitation program. In addition, nonsterile wipes were used for disinfection, and items introduced to a cleanroom were not disinfected properly.

Workers also improperly left their skin and eyes exposed as they worked in the cleanrooms, according to the letter.

In addition, Ionia did not establish or follow appropriate written procedures designed to prevent microbiological contamination of sterile products. The company also did not have an adequate stability testing program to determine appropriate storage conditions and expiration dates.

In its response to a Form 483, Ionia said it would be closing up shop. However, the agency has yet to receive confirmation that the pharmacy has closed its doors, the warning letter states. If it remains open, the FDA recommends it undertake a comprehensive assessment of its operations and engage a third-party consultant.

Meanwhile, at Spoonamore, an inspection conducted between Jan. 13 and Feb. 3, 2015, found that the company didn’t use a sporicidal agent as part of its disinfection program in the cleanroom, according to the agency’s Dec. 18, 2015, warning letter.

The inspection also revealed that the pharmacy produced domperidone, a medication prescribed to ease nausea that has not been approved by the FDA and thus shouldn’t be used for compounding.  The company has said it no longer makes the product.

A spokesman for Spoonamore said the pharmacy is working with the FDA “to resolve the allegations concerning the pharmacy’s compounding practices.” Ionia did not respond to a request for comment by press time.

Read the Ionia warning letter here: www.fdanews.com/01-13-16-IoniaPharmacy.pdf and the Spoonamore facility warning here: www.fdanews.com/01-13-16-SpoonamoreDrugCoInc.pdf.