FDA 483 - FMKLABS - March 08, 2019

An FDA inspection conducted from March 4-8, 2019, identified significant deficiencies at a manufacturing facility (company name not specified in the document). The observations, detailed in an FDA Form 483, indicate a lack of adherence to Current Good Manufacturing Practices (cGMP) regulations. Key issues included inadequate employee training, where personnel were either not trained on effective SOPs in a timely manner, trained on unapproved procedures, or lacked specific training details and annual cGMP refreshers. The firm also failed to consistently follow written procedures for component approval and rejection, evidenced by discrepancies in water result reporting and approval dates. Furthermore, batch production and control records were incomplete, missing critical information such as mixing durations, process parameters, and equipment IDs. Investigations into unexplained discrepancies in batch records, like reconciliation sheet variations, were absent. The company also failed to conduct annual product reviews for its Over-The-Counter (OTC) products and lacked proper qualification documentation for manufacturing equipment. Finally, there were no written procedures or validation reports for equipment cleaning and maintenance. These observations collectively require the firm to implement comprehensive corrective actions to ensure compliance with regulatory standards.