Repeat CGMP Violations at Vitae Enim Vitae

A 9/13-9/22/21 FDA inspection at the Vitae Enim Vitae Scientific drug manufacturing facility in San Diego, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 3/17 Warning Letter says specific violations were: 

•          failing to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
•          failingto establish an adequate system for monitoring environmental conditions in aseptic processing areas;
•          failure of the firm’s quality control unit to exercise its responsibility to ensure drug products are manufactured in compliance with CGMP and meet established specifications for identity, strength, quality, and purity;
•          failing 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 has already been distributed; and
•          failing to establish and follow adequate control procedures to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. 

The letter says similar CGMP observations were cited in a 2/2-2/27/19 inspection and the firm proposed specific remediation for the observations in its response. “Repeated failures to address deficient operations demonstrate that executive management oversight and control is inadequate,” FDA says, recommending that the firm retain a qualified consultant to assist it in meeting CGMP requirements.

The letter reminds Vitae that it is responsible for the quality of the drugs it produces as a contract facility regardless of agreements in place with application sponsors and product owners.

FDA acknowledges that Vitae initiated a recall of all products intended to be sterile that are within expiry after its discussions with the agency. Vitae was told to schedule a meeting with FDA.

The letter directs Vitae to correct any violations promptly and to respond with a list of specific actions it has taken to correct the violations and prevent their recurrence, with a schedule for completing the corrections.