Our clients are continually faced with resource, workload, and time constraints, and lack of a proven approach and methodology to address compliance remediation corrective actions for documentation, data integrity, workflow, and quality systems. A “band aid” approach is often taken and the corrective action may not be viewed as adequate and sustainable by the FDA.
Malcom Associates provides solutions to help clients resolve and implement corrective actions needed to address Form 483 observations or Warning Letter violations. With Warning Letters, our clients have received FDA close-out letters for completing commitments on time and in some cases ahead of schedule.
“I didn’t think we would be able to meet the schedule on the Batch Records that had been committed to, but we did it, a number of them have been approved and are in use and the response from the operators and QA has been very positive.”
– Operations Director