Pharmaceutical Manufacturer Compliance Team Lead – Timothy E. Allen | Former Special Agent (U.S. Secret Service & DOJ-OIG)
When external audit processes go wrong in pharmaceutical companies, Corporate Investigation Consulting can come in with the necessary external audit defenses and save the day.
Pharmaceutical manufacturing companies require routine external audits to ensure they are complying with applicable regulations and industry standards. External audits focus on the financials i.e., accuracy and adherence to reporting standards as per regulators and contractual agreements. External audits can involve investigating computerized records on drug manufacturing and invoice records. They may also be triggered by suspected problems i.e., noncompliance with demanded standards.
If external audits are done, and a pharmaceutical manufacturer is found to be noncompliant or guilty of malpractice, the manufacturer can face legal problems, hefty fines, licensing problems, reputation damage, and more.
Corporate Investigation Consulting can challenge external audits that yield unfavorable outcomes. While healthcare regulators like the FDA conduct routine audits on pharmaceutical manufacturers and other players in the U.S. healthcare industry, external audits can be triggered by malicious rumors from competitors or former disgruntled employees.
External audits can also be done illegally or irregularly. We have seasoned legal professionals who understand how external audits should be done. Our external audit defense services challenge negative audit results on many aspects, including what triggers them, how they are conducted, how evidence is collected, etc.
Pharmaceutical manufacturers that have been unfairly subjected to external audits can call us today – 866-352-9324. We have a free-confidential, non-obligatory consultation.
Put our highly experienced team on your side
Roger Bach
Former Special Agent (OIG)
Timothy E. Allen
Former Senior Special Agent U.S. Secret Service
Chris J. Quick
Former Special Agent (FBI & IRS-CI)
Maura Kelley
Former Special Agent (FBI)
Ray Yuen
Former Supervisory Special Agent (FBI)
Michael S. Koslow
Former Supervisory Special Agent (DOD-OIG)
Marquis D. Pickett
Special Agent U.S. Secret Service (ret.)
How Should an External Audit be Done in a Pharmaceutical Manufacturing Facility?
One of the main external audit defenses targets the process of conducting audits. Audits follow a systematic process:
Step 1. Pre-audit
Audits that fail to follow due processes can be challenged. Before an external audit is done, an auditor should inform the pharmaceutical company prior to the audit process to ensure auditors are furnished with the information or assistance they need.
Auditors focus on pharmaceutical manufacturers for many reasons ranging from regulatory compliance to detecting fraud. Auditors should request audit documentation and facilitation in time to allow preparation. Pre-audit questionnaires are good examples of pre-audit documents.
Different auditors must follow specific pre-audit rules. Corporate Investigation Consulting can assess pre-audit procedures unique to different auditors and prepare an effective external audit defense based on pre-audit mistakes.
Step 2. Preparation
Pre-audit processes are followed by contact with a pharmaceutical manufacturing company’s management in advance to gather information, agree on audit agenda and allow other arrangements. Auditors should use pre-audit questionnaires and audit reports submitted in the pre-audit process to prepare and save time during audits. Auditors also need to plan on how they will handle sensitive/highly confidential information to avoid conflict/risk during the audit.
Step 3. Auditing
The third step is the actual audit process, which begins with an introduction between auditors and the pharmaceutical company’s staff. While pharmaceutical regulators like the FDA and agencies like the DEA can conduct abrupt external audits on pharmaceutical companies in some circumstances, they should follow procedure.
The audit process should begin with such auditors explaining their audit rationale, objectives, scope, and audit timeline. They also need to clarify how confidential information, samples, safety, etc. will be handled. Typical external audit processes in a pharmaceutical manufacturing company involve processes such as examining R&D costs on new drugs and assessing the integrity of internal financial controls limiting inappropriate practices.
Step 4. Reporting
Auditors are supposed to create and submit an audit report. Before releasing such a report, the auditee should have the opportunity to comment on audit findings. Generally, pharmaceutical manufacturers subjected to external audits can verify factual findings to avoid misunderstandings in observations and recommendations.
The above information is obviously an oversimplification of how external audits involving pharmaceutical manufacturers are supposed to be conducted. You need experts to interrogate the external audit process and establish if it was done properly. Experts like us can also offer external audit defenses challenging any unprocedural aspect of an audit.
Addressing External Audit Issues for Pharmaceutical Manufacturers
Generally, auditees should have an opportunity to respond. For instance, auditors testing transactions in a pharmaceutical company for legitimacy or fraud should disclose such inconsistencies or findings via a report submitted to the management team. Such issues must be discussed to give room for an amicable solution to every issue.
A pharmaceutical company’s management should be open to discussing any concerns. Managers that take a proactive stance make audit processes better for auditors and themselves. Being proactive shows that you are part of the solution. However, management should be careful of acknowledging problems formally in the absence of legal expertise. It is recommendable to seek an auditor’s guidance on the right course of action. However, formally admitting wrongdoing isn’t advisable.
We assist our clients in interpreting external audit findings and reports and advising on the next best course of action. Effective auditors may want to discuss findings with management before preparing an audit report. We offer legal assistance when responding to auditor questions. We can craft corrective actions for every audit finding identified in an audit report. We can also facilitate documentary evidence showing that audit concerns have been addressed.
Our Advantage
- We don’t just supervise external audits. In case of legal disputes arising from external audits, we can defend pharmaceutical companies. We can also implement corrective actions and keep documentation on the same to support legal proceedings that may arise in follow-up audits.
- Our services also ensure pharmaceutical manufacturers don’t make common, costly mistakes like incriminating themselves, damaging their reputation, or paying hefty fines that affect cashflow and compromise operations.
- We’ve helped many pharmaceutical companies avoid closure and reputation problems by interrogating auditors on their reasons/motivation for audits and questioning evidence collection methods.
- We have presence nationwide, which allows us to defend any pharmaceutical manufacturer in the U.S. regardless of jurisdiction. We understand all state regulations governing audits in the pharmaceutical industry.
- Corporate Investigation Consulting also has proven experts. Check our vast team knowledgeable in many aspects. We have former special agents, legal experts, and all other experts and consultants needed in external audit defense matters.
Request a free-non-obligatory & confidential external audit consultation to understand in-depth what we do for pharmaceutical manufacturing companies that face external audit issues. Contact us today.