Can the FDA Direct You to Hire a Consultant?
(Thursday, October 19, 2023)
Last week, the FDA directed a South Korean drug manufacturer to hire a consultant to help with numerous non-compliance observations during an audit of their manufacturing facilities in South Korea. Such “suggestions” to audited parties to hire external experts are occasionally made in Warning Letters. But are the manufacturers obliged to follow through?
FDA audits occasionally find the audited party to be grossly unaware of the regulations and guidance documents. This is particularly true for sites going through their first FDA audit, possibly located outside the US, and employing personnel less familiar with US requirements. Generally, the FDA auditors would try to discuss the non-compliance findings with the audited party and give them opportunities to rectify the errors. But it could happen that despite repeated attempts, the site is unable to either understand the FDA instructions properly or seems unwilling to listen. In such cases, the FDA would likely advise the site to hire an independent outside consultant or expert to help them get compliant. The FDA's “recommendation” to hire a consultant is a gentle hint from the FDA about the site’s inability to self-address the issues based on the result of an assessment of multiple basic compliance matters.
In a week-long audit of the GMP facilities of Seoul Cosmetics Co. Ltd, the FDA auditors found many issues with basic GMP compliance. These included deficiencies in the quality testing procedures, documentation, and overall quality systems. Drug companies must hire consultants to help them understand the applicable requirements when they lack internal resources for the same. Per 21 CFR 211.34, the consultant(s) must be qualified by education, training, and experience in applicable FDA regulations and guidelines. There is no certification requirement for the consultant; the hiring party is expected to self-assess the quality of the consultant prior to hiring. Having a consultant does not absolve the company from its obligations though.
Although the FDA does not and cannot force a company to hire consultants, having one could be a part of the corrective and preventive actions in response to the FDA audit. In our experience, including the details of the independent consultation obtained and implemented in the response to the FDA goes a long way in building the FDA’s confidence in the ability of the site to be compliant.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC