Success Stories

Meridan Consulting has a long-standing history of success when it comes to helping companies navigate the difficult path from a violative FDA inspection to an acceptable compliance profile. We also direct firms on how to develop and maintain systems that are aligned with current industry ‘best practices’, and set the company up for success. The goal is to “Always Be Inspection Ready” and never have to navigate the difficult path back to an acceptable compliance profile. Some recent success stories include:

Data Integrity Violations

2014 – Remediation consulting company of record for an Indian-based finished dosage manufacturing firm that received a 483 for analytical laboratory data integrity violations. Site clearance was received within 3 months.

Supply Chain Security and Temperature Control

2015 – Awarded ‘Specialty Service Provider of the Year’ for a US-based Fortune 500 company for completed projects related to supply chain security and temperature control.

Import Alert

2016 – Remediation and product assessment consulting company of record for an Indian-based API and finished dosage manufacturing company placed under import alert for data integrity violations. Over 150 batches were independently assessed as a condition of import alert exemption, prior to release to the US market. Remediation strategy and progress was presented to FDA on multiple occasions. Remediation was deemed satisfactory by FDA and the import alert was lifted for both sites.

Certification Program

2017 – Designed a certification program for an Indian-based finished dosage manufacturing company that was placed under import alert for data integrity violations. Remediation was deemed satisfactory by FDA during a subsequent inspection and import alert was lifted.