Case Studies
Compliance Assurance Leads to Passed FDA Inspection
Client
Qualitest
Industry
Pharmaceuticals
Business Challenge
Preparing for an FDA audit by investigating, suggest improvements, and identifying areas of risk
Background
Qualitest, a leading developer and manufacturer of affordable, high-quality generic pharmaceuticals, wanted to be prepared for upcoming FDA inspections.
RCA Approach
Qualitest engaged Regulatory Compliance Associates® Inc. (RCA) to prepare the company in advance of an FDA Audit. RCA reviewed over 170 investigations relating to Qualitest operations to suggest improvements and identify areas of risk. By working efficiently and by tapping into scheduled downtime, RCA was able to complete the project in three months.
“RCA not only remediated our warning letter, but they also improved our workforce efficiency and preparedness for agency audits. We didn’t realize what it took to be prepared for an inspection. Prior to RCA, we had cursory reviews by auditors and inspectors, but we always suspected there were issues that weren’t identified. We experienced a thorough inspection when RCA came. Our systems were closely examined by RCA’s mock inspectors, to the point where we really felt like we had been through a real inspection. They identified many deficiencies and areas for process improvement. We now know we are in good shape and are getting better by practicing what we learned. RCA provided great value to us.”
Result
Qualitest implemented the recommended changes, including company-wide training, and received no observations during the next FDA inspection.
