FDA 483 - Unknown Company - June 27, 2018

An FDA inspection of Kalman Health & Wellness, Inc. dba Essential Wellness Pharma 2, a producer of non-sterile drugs in Peoria, IL, was conducted from June 19 to June 27, 2018. The inspection resulted in a Form FDA 483, documenting two significant observations related to manufacturing practices.

Firstly, the company's procedures for cleaning and sanitization of common, non-dedicated equipment used in drug product manufacturing were found to be insufficient. There was no objective evidence to confirm these procedures effectively prevent contamination or cross-contamination, particularly with potent drugs or beta-lactams, which is critical for product safety.

Secondly, the firm was observed using unvalidated water from plastic containers for human drug product manufacturing, specifically Dexamethasone Ionto 4 mg/mL. The FDA noted a lack of objective evidence demonstrating that this water was of sufficient quality for pharmaceutical purposes.

These observations indicate potential deficiencies in the company's adherence to regulatory manufacturing standards. While the FDA 483 is an inspectional observation report, it necessitates the company to review and implement corrective actions to address these concerns and ensure compliance with quality and safety regulations for drug production.