FDA 483 - Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P. - March 24, 2017

This FDA Form 483 document details multiple observations from an inspection, indicating significant deficiencies in the facility's quality system and manufacturing processes.

Key violations include: * **Failure to thoroughly review discrepancies:** Unexplained discrepancies and out-of-specification batches are not adequately reviewed, even if distributed. * **Lack of process control procedures:** Control procedures are not established to monitor output and validate manufacturing processes, leading to variability in in-process materials and drug products. * **Inadequate complaint handling:** Procedures for managing written and oral drug product complaints are not established, written, or followed. * **Insufficient statistical techniques:** Procedures for identifying valid statistical techniques for process capability and product characteristics are not adequately established. * **Poor recordkeeping for quality review:** Records are not maintained for annual review to evaluate quality standards and determine the need for changes in specifications or procedures. * **Deficient design control procedures:** Procedures for design input, output, verification, and validation are not adequately established. * **Inadequate laboratory controls:** Laboratory controls lack scientifically sound specifications, standards, sampling plans, and test procedures for components, containers, closures, in-process materials, labeling, and drug products. * **Lack of QC unit authority:** The quality control unit lacks the responsibility and authority to approve and reject all components, materials, and drug products. * **Failure to prevent microbiological contamination:** Procedures to prevent microbiological contamination of sterile