FDA Warning Letters Sent to California and Kentucky Compounders

The FDA recently issued two warning letters to compounders in California and Kentucky for violating current good manufacturing practices related to sterility.

Ionia Pharmacy, based in Tustin, California, and Spoonamore Drug Co., located in Louisville, Kentucky, were both issued warning letters for deficiencies in:

  1. Producing sterile drug products and putting patients at risk,
  2. Not receiving valid prescriptions for individually identified patients,
  3. Misbranded drug products; and
  4. Poorly written guidelines.
FDA inspectors sighted a lack of effectiveness in Ionia’s cleaning and sanitation program, specifically that non sterile wipes were being used for disinfection and that items brought into a cleanroom were not properly disinfected. Also, Ionia failed to establish or follow the required written procedures designed to prevent microbiological contamination of sterile products and did not have an adequate stability testing program to determine appropriate storage conditions and expiration dates. Finally, FDA inspectors found that Ionia workers were improperly dressed while working in the cleanrooms, leaving their skin and eyes exposed. 

Ionia, in response to the FDA’s noted deficiencies, stated that it would cease all operations and close. The FDA, however, has not received confirmation of Ionia closing.

Inspections at Spoonamore revealed that Spoonamore did not use a sporadical agent as part of its disinfection program in its cleanroom. Additionally, FDA inspectors found that Spoonamore produced domperidone, a medication commonly used to treat nausea and vomiting, that has not been approved by the FDA for use in the United States and therefore should not be used in compounding. Spoonamore reportedly has stopped producing domperidone.

Stay tuned to the Baer Law Blog for more compounding updates.