FDA 483 - Symrise, S. de R.L de C.V. - September 21, 2018

The FDA conducted an inspection of Symrise, S. de R.L. de C.V., a manufacturing facility located in San Nicolas de los Garza, Nuevo Leon, Mexico, from July 17 to July 22, 2018. The inspection identified several significant compliance issues related to quality control and manufacturing processes. Key observations included a lack of oversight by the Quality Unit over document control, specifically in the issuance of batch and production control records. Additionally, there were no established written procedures for production and process controls to ensure drug products meet required identity, strength, quality, and purity standards. The facility also failed to conduct necessary process validations for drug manufacturing, including documenting the number of process repetitions for active pharmaceutical ingredients (APIs).

Furthermore, deficiencies were noted in batch production and control records, which did not accurately reflect the master production records. Laboratory controls were inadequate, lacking scientifically sound standards and procedures for testing and validation, such as the cleaning validation protocol and calibration of laboratory equipment.

The FDA's observations highlight the need for Symrise to implement corrective actions to address these compliance issues. The company is responsible for conducting internal audits to identify and rectify all violations of quality system requirements. Symrise is expected to develop and enforce comprehensive written procedures, ensure proper documentation, and establish scientifically sound laboratory controls to comply with regulatory standards.