FDA 483 - PRIMA FLEUR BOTANICALS INC - October 30, 2024

An FDA inspection conducted from October 23 to October 30, 2024, at an unnamed firm (company name not specified in the document), revealed significant deficiencies in its manufacturing and quality systems for drug products, primarily hand sanitizers. The inspection resulted in six observations, indicating critical deviations from Current Good Manufacturing Practices (CGMP) under the Federal Food, Drug, and Cosmetic Act.

Key issues included a severely inadequate quality control unit, lacking written procedures for core functions such as investigations, corrective and preventive actions (CAPA), annual product reviews, and employee training. The firm also failed to establish testing protocols for components and finished products, and comprehensive equipment logbooks were absent. Critically, finished product release testing, confirming the identity and strength of active ingredients in hand sanitizer lots, was not performed.

Furthermore, the company lacked a written stability program to assess drug product characteristics and establish expiration dates. There were no written procedures for production and process controls, and process validation for hand sanitizer products was not conducted. Batch production records were incomplete, missing vital information on components, equipment, yields, and labeling. Lastly, manufacturing equipment, such as a specific water system, was not qualified or validated, and sanitization protocols were absent. The firm is required to implement comprehensive corrective actions to address these systemic issues and ensure compliance with CGMP regulations.