Mock FDA Inspections

Reviewing of FDA inspection cycles finds that their visits may range from 6 months to 10 years. Most companies want to predict and plan for when FDA inspects. In addition, numerous companies have had a difficult inspection history, with a lengthy FDA-483, or a recent Warning Letter. In all of those cases you should consider mock inspections.

Mock inspections serve as a rehearsal for the real thing. It is far better to get the bugs out of your system during the rehearsal inspection than during the actual FDA inspection.

IQCDS performs numerous mock inspections each year. Our clients want the knowledge of what might happen during the inspection as well as where are their GMP and Quality System vulnerabilities may be. An audit by an outside party, with a fresh pair of eyes, is something you should consider, regardless of your internal audit program.

One advantage of the IQCDS audit or mock inspection is that we can perform the work using someone who also was an Investigator with FDA. We also can provide the audit using a non-ex-FDA individual. The call is yours.

The value our service is that you get both a valuable opportunity to learn more about:

  • Your system and process for handling inspections, (including the efficiency and skills of your inspection coordinator and ready room staff) and
  • Your state GMPs and Quality Systems compliance.

Some companies have asked IQCDS to perform a mock inspection in lieu of a company (high level) audit. We can provide this service. We can work with you, using your internal audit procedures and provide the needed audit results.  Our audits include the following:

  • An audit plan that you approve in advance.
  • An audit or mock inspection (some clients want both).
  • A list of findings, both potential FDA-483 items as well as logistical findings.
  • An audit report (formatted with your needs in mind).

We only use the highest quality personnel for the audit or mock inspection. Our auditors are ex-FDA personnel with inspection experience or ex-industry personnel with lead auditor credentials. As does FDA, we can also provide technical assistance from our vast network of associates to assist on these projects if you desire such added expertise.

To discuss Audits for your company please contact us at (949) 235-6037 or email us at info@iqcds.com.

International Quality Consulting bring a diverse team of consultants to our clients. We are constantly expanding our roster of internationally recognized associates. Our trainers and consultants average over 30 years experience in the FDA regulated environment – many of which are ex-FDA. Our associates bring a wealth of experience to help meet your consulting and training needs.

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