FDA 483 - Kindeva Drug Delivery LP - April 03, 2024

During an inspection from April 1-3, 2024, Kindeva Drug Delivery LP, a contract testing laboratory in Woodbury, MN, received an FDA Form 483 detailing significant observations. The primary concerns revolved around deficiencies in laboratory controls and quality unit procedures, particularly impacting the testing of albuterol sulfate MDI.Firstly, the FDA noted inadequate laboratory controls. A method transfer for a purity assay (Method-07-000337) lacked comparability testing between sites and failed to demonstrate the ability to quantify impurities. Additionally, there was no detailed procedure for chromatography data integration, and the system allowed analysts to change integrations without requiring audit trail capture, compromising data integrity.Secondly, the quality control unit’s responsibilities and procedures were found to be insufficient. A standard operating procedure (GSOP-07-000028) for reviewing electronic data, including audit trails, lacked specificity, and expanded audit trail reviews were not performed. Furthermore, unvalidated spreadsheets were used for critical calculations (GSOP-07-000051), violating validation requirements.Finally, the firm failed to maintain backup files for electronic raw data generated from instruments used in release testing for albuterol sulfate MDI, posing a risk to data security and retrievability.These observations highlight deviations from regulatory expectations, indicating a need for Kindeva Drug Delivery LP to implement comprehensive corrective actions to ensure compliance with standards for drug product testing and data integrity.