FDA 483 - Wickliffe Pharmaceutical Inc - April 07, 2016

An FDA inspection of Wickliffe Pharmaceutical Inc., a producer of veterinary drug products, was conducted from February 22 to April 7, 2016. The inspection revealed two significant observations indicating potential deviations from Good Manufacturing Practices.

The first observation concerned inadequate reprocessing procedures. For a batch of Pentosan Polysulfate 250 mg/mL Injectable (Lot 23-12-2014@9), particulates were found post-distribution, leading to a recall. While the firm reprocessed the remaining product, they failed to investigate the particulate source or nature, and lacked assurance that the reprocessing successfully removed all particulates, compromising product quality control.

The second observation highlighted the absence of an effective system for tracking drug product distribution, which is critical for facilitating recalls. The firm demonstrated deficiencies across multiple recalled products, including Magnesium Sulfate Injectable and Cyclosporin A 2% Ophthalmic Solution. These shortcomings involved a lack of clarity regarding recall reasons, inconsistent customer notification, unconfirmed product returns, and undefined final disposition of recalled items.

Wickliffe Pharmaceutical Inc. is expected to implement corrective actions to address these observations. This includes establishing robust reprocessing protocols with thorough investigations for product failures, and developing a comprehensive and traceable system for product distribution and recall management to ensure compliance and maintain product safety standards.