FDA 483 - Kohana Pharmacy and Center for Regenerative Medicine Inc. - April 17, 2019

During an inspection conducted from April 10-17, 2019, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Kohana Pharmacy and Center for Regenerative Medicine Inc., a producer of non-sterile drug products in San Luis Obispo, CA. This document outlines significant observations requiring prompt attention to ensure compliance with drug manufacturing standards.

The first observation cited the use of non-pharmaceutical grade components in the formulation of multiple non-sterile drug products. Examples included Loperamide HCl Oral Suspension, a multi-component cream (Diclofenac, Baclofen, Cyclobenzaprine, Gabapentin, Tetracaine), and various nasal sprays (Ketamine, Oxytocin, Itraconazole/EDTA/Gentamycin). This practice raises concerns regarding the quality, safety, and efficacy of the compounded medications.

The second observation identified inadequate cleaning procedures for hazardous drug production. The pharmacy lacked dedicated utensils for hazardous drugs; those used were cleaned and then commingled with utensils for non-hazardous drugs. This presents a substantial risk of cross-contamination, potentially compromising the safety and purity of both hazardous and non-hazardous preparations, especially given the daily production volume of various drug products.

In response to these findings, Kohana Pharmacy is expected to implement comprehensive corrective actions to address the identified deficiencies and prevent recurrence, ensuring adherence to appropriate drug compounding and manufacturing practices.