Last year in 2019, FDA investigators issued almost 800 Form 483s to drug manufacturing facilities. Experienced QA auditors could have identified those issues before the FDA did. Not only does an inadequate audit program leave you vulnerable to regulatory enforcement action, but it is, itself, often cited as a violation.
You don’t have to jeopardize your business or your status with regulatory bodies. And you don’t have to worry that you’re unknowingly out of compliance with CGMP regulations. We can help you. Our auditors’ in-depth knowledge of domestic and international regulations, and their hands-on CGMP experience, can take the uncertainty out of GMP compliance.
Each day your Good Manufacturing Practice compliance goes unconfirmed, you jeopardize both your business and your status with the FDA. Don’t continue to worry about your GMP compliance. Contact Polaris today.
We conduct compliance audits and save time to market for our customers worldwide. How can we help you?
Polaris Compliance Consultants, Inc. 1151 Executive Circle Suite 202
Cary, NC 27511-4589 (919) 463-0003