The QMN Weekly Bulletin

FDA Issues Warning Letters to California and Kentucky Compounders

March 18, 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., in Louisville, Ky., were warned about deficiencies in producing sterile drug products; 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 Pharmacy 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 firm’s cleaning and sanitation program. Workers also left their skin and eyes exposed as they worked in the cleanrooms, according to the letter.

Ionia also did not establish written procedures to prevent contamination of sterile products. It also didn’t 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 Drug Co., 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 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.

Spoonamore said the pharmacy is working with the FDA to resolve the allegations concerning its compounding practices. Ionia did not respond to a request for comment.

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