FDA 483 - Emergent Manufacturing Operations Baltimore LLC. - April 20, 2020

This FDA Form 483 details observations from an inspection, highlighting significant deficiencies in quality control, data integrity, and personnel training.

**Observation 1** addresses inadequate controls over computer systems. The Quality Unit failed to protect electronically held analytical data from deletion or manipulation and did not review audit trails, with no investigations into the impact of these issues on drug substance and product analyzed until December 2019. Analytical balances and computer operating systems allowed users to change dates and times on records and system settings, compromising data integrity.

**Observation 2** notes deviations from established specifications, test procedures, and laboratory control mechanisms. Sample identification numbers were inconsistently corrected days after data acquisition without investigation or justification. Deviations from test methods were manually corrected days later without supporting data. Documentation for stability sample analysis lacked information on sample storage conditions between analyses.

**Observation 3** identifies issues with the Quality Control Unit's responsibilities and procedures. SOP024317, "QC Investigations and Invalid Events," permits the analyst who generated an invalid event to perform the investigation, and allows verbal approval for repeat tests before full documentation and secondary review. Additionally, SOP00299, "Review of Quality Control (QC) Data," which requires data review within a specified timeframe, was routinely violated without justification.

**Observation 4** points to inadequate employee training. A preparer of solutions for HPLC was not documented on the employee signature log, preventing traceability to training records