CGMP Violations at Exela Pharma Sciences

An 11/4-11/15/2024 FDA inspection at the Exela Pharma Sciences outsourcing drug manufacturing facility in Lenoir, NC, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 7/2 Warning Letter says the specific violations were:

• failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch had already been distributed;
• failure to ensure that laboratory results included complete data derived from all tests necessary to ensure compliance with established specifications and standards;
• failure to establish written procedures for production and process control designed to assure that manufactured drug products have the identity, strength, quality, and purity they purport or are represented to possess;
• failure to conduct laboratory testing to determine whether each batch of drug product purporting to be sterile conforms to such requirements;
• failure of laboratory records to include the initials and signature of the second person reviewing the record for accuracy;
• failure to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use the results of stability testing to determine appropriate storage conditions and expiration dates;
• failure to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable the person to perform his or her assigned functions; and
• failure to establish acceptance criteria for the sampling and testing conducted by the quality control unit that are adequate to assure that batches of drug products meet each appropriate specification and appropriate statistical quality control criteria as a condition for their approval and release.

FDA acknowledges that Exela deregistered as an outsourcing facility as of 12/20/2024. It says that some of the firm’s corrective actions in response to a form FDA-483 appear adequate, while the agency was unable to fully evaluate some other responses due to a lack of adequate supporting documentation. Some of the corrective actions appear deficient, the agency says.

Exela was told to correct violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections. FDA reminds the firm that if it decides to resume outsourcing operations, it should act promptly to address any violations.