FDA 483 - Dalton Chemical Laboratories Inc. - December 09, 2022

An FDA inspection conducted at Dalton Chemical Laboratories Inc., a drug manufacturer in North York, from December 1 to December 9, 2022, revealed significant deficiencies across multiple operational areas. The observations, detailed in an FDA 483 report issued to CEO Peter Pekos, primarily highlight non-compliance with Current Good Manufacturing Practices (cGMP), particularly concerning sterile drug production and quality control.Key violations included inadequate procedures to prevent microbiological contamination during aseptic processing. Investigators noted operators failing to sanitize equipment and hands within Restricted Access Barrier Systems (RABS), and the firm’s smoke studies for RABS airflow were incomplete or outdated, failing to validate critical areas. Deficiencies in media fill simulations were also identified, including insufficient batch sizes and investigations into failed runs.Further issues involved the lack of adequate written procedures for production and process controls, evidenced by unvalidated hold times for critical manufacturing steps and insufficient sampling to establish product saturation periods. The firm also failed to thoroughly investigate Out-of-Specification (OOS) results for endotoxin, releasing products without fully identifying root causes. Moreover, stability testing results did not support the proposed expiration dates for certain drug solutions, with OOS and Out-of-Trend observations. Laboratory control weaknesses included questionable environmental monitoring practices and data integrity concerns regarding HPLC integration parameters. Finally, cleaning validation for critical equipment was found to be inadequate, lacking microbiological testing and validation of cleaning hold times.To address these serious observations, Dalton Chemical Laboratories Inc. is required to implement comprehensive corrective and preventive actions, revise procedures, and provide documented evidence of sustained compliance with cGMP regulations to ensure the safety, identity, strength, quality, and purity of its drug products.