FDA 483 - National Chemical Laboratories - May 26, 2023

During an FDA inspection conducted from May 22-26, 2023, National Chemical Laboratories, an Over-The-Counter (OTC) drug manufacturer, was issued a Form FDA 483. The inspection revealed several significant observations concerning the company's adherence to established manufacturing standards for products such as Afia Alcohol-Free Foaming Hand Sanitizer and Afia Anti-Bacterial Foaming Hand Cleaner.Key issues included a substantial lack of written procedures and validation studies for critical quality control and production processes. The quality control unit lacked protocols for managing out-of-specification results, deviations, raw material vendor qualification, and equipment cleaning/validation. Furthermore, the firm had no formal stability testing program to support product expiration dates and failed to properly validate supplier certificates of analysis for raw materials like benzalkonium chloride.Additional deficiencies encompassed the absence of written equipment cleaning procedures and associated validation, along with a failure to perform process validation studies for finished drug products. Facility maintenance also presented concerns, with observations of water-stained ceilings and unprotected lighting in manufacturing and quality control areas.National Chemical Laboratories is required to implement comprehensive corrective actions to address these observations, focusing on developing and executing robust procedures, programs, and validations to ensure its OTC drug products meet regulatory quality, safety, and efficacy standards.