FDA 483 - Organo Sintesis, S.A. De C.V. - July 28, 2023

An FDA inspection conducted at Organo Sintesis, S.A. de C.V., an Active Pharmaceutical Ingredient (API) manufacturer in San Nicolas Tlazala, Mexico, from July 24-28, 2023, revealed significant concerns regarding the company's adherence to Good Manufacturing Practices. The inspection documented six observations indicating systemic failures in quality control and data integrity.Key issues included a failure to ensure APIs meet established quality specifications, with noted deficiencies in change control documentation, justification for R&D recommendation cancellations, and the rework of batches without proper procedures. The microbiology laboratory was found not to follow USP growth promotion processes, potentially compromising data reliability. Furthermore, the firm lacked adequate controls over computerized systems to prevent unauthorized data changes and ensure electronic data integrity in the QC lab.Environmental controls were insufficient, with uncontrolled temperatures and humidity in production and warehouse areas reaching up to 90°F, posing a contamination risk. The company also failed to ensure complete employee training on CGMP and operational procedures. Finally, extensive deficiencies in laboratory control records were identified, including unrecorded incubation dates, use of expired pH buffers for calibration, and the use of an uncalibrated pH meter following an out-of-specification reading. Organo Sintesis is required to address these observations promptly to comply with regulatory standards and ensure product quality and safety.