Qualgen, LLC – FDA 483, Sep 30, 2022

An FDA Form 483 was issued to Qualgen, LLC, a producer of sterile drugs in Edmond, OK, following an inspection conducted from September 13 to September 30, 2022. The inspection revealed significant deficiencies across multiple areas of operation, indicating a failure to adhere to established manufacturing standards. Key issues included the quality control unit not fully following or documenting procedures, such as work order completion, assessment of cleaning/disinfection effectiveness, and proper re-packing of non-sterile components without adequate bioburden risk assessment. The firm also failed to conduct required in-process material examinations, released drug products that did not meet specifications (e.g., testosterone/cholesterol pellets failing thickness), and did not consistently follow procedures for handling customer complaints, leaving several uninvestigated or lacking conclusions. Further observations highlighted inadequate validation of sterilization processes, insufficient laboratory controls due to the use of non-pharmaceutical grade reagents, and a lack of written procedures for cleaning agents. Batch production records were found deficient in API weighing, labeling, and documenting time limit deviations. Additionally, drug product labels lacked essential information, such as quantity or volume. These observations, issued under the Federal Food, Drug, and Cosmetic Act, require Qualgen, LLC to implement comprehensive corrective actions to address these systemic issues and ensure compliance with regulatory expectations.