FDA 483 - Wickliffe Pharmaceutical Inc - May 22, 2014

This FDA Form 483 document details inspectional observations made at Wickliffe Pharmaceutical Inc., a compounding pharmacy located at 4340 Georgetown Rd., Lexington, KY 40511. The inspection was conducted on April 29-30, 2014, and May 9, 14, 22, 2014, by Kathleen Dant Culver, Investigator/Drug Preapproval Manager. The report is issued to Jacqueline S. Bernard, President and Owner.

Two key observations relate to the potency of compounded drug products:

1. **Lot 28-03-2014@44 (BUD 9/24/2014) of toltrazuril and pyrimethamine suspension**, labeled to contain 416 mg/ml toltrazuril and 17 mg/ml pyrimethamine, and dispensed under Rx #294545, showed significant deviations: * Pyrimethamine was found at 405 +/- 69 mg/ml, which is 2380% of the declared potency. * Toltrazuril was found at 15.5 +/- 2.5 mg/ml, which is 3.74% of the declared potency.

2. **Lot 25-03-20