Data Integrity, Lab Control Issues Lead to Form 483s for Two Manufacturers

The FDA issued Form 483s to two drug manufacturers for data integrity and laboratory issues.

Investigators listed four observations in its review of DLC Laboratories, including a failure to maintain data backup files. The letter notes that the firm uses electronic records, but does not meet standards for retention, system access limits, audit trails and authority checkpoints.

In addition, the firm’s analysts have full user privileges to electronic records, including manual integration and modification of data, and there is no oversight to review the audit trail and electronic data after the completion of an analysis.