Mock Up FDA Inspections by a former FDA Investigator
ALP Sourcing performs only one type of consulting for medical device and pharmaceutical drug manufacturers: mock up FDA inspections. We have been doing that for the past 30 years, and we are the best at what we do. We have both the experience and knowledge needed to inspect media fills, raw chemicals, quality laboratory and microbiological testing, sterility testing, sampling, cleaning, process validation, environmental monitoring, pure water systems, sterilization, computer system validation, design controls, storage, and distribution.
Moreover, we can review your batch records. We have done all of that for the past 30 years, both as FDA investigators and as consultants. We understand both sides of the process because we have been in the FDA as well as in the industry. In that sense, we can wear both the “white hat” and “black hat” at the same time during mock FDA audits. As such, we can offer a major benefit to your organization. We bring both kinds of experience to the table and conduct audits that “feed two birds with one seed,” so to speak.
Medical device and pharmaceutical drug manufacturers face some of the most difficult challenges from both regulators and the public. You do not want to generate any more negative public opinion than already exists by neglecting to perform mock FDA audits. ALP Sourcinghas inspected drug manufacturing operations around the globe. We can share what we have learned without compromising our clients’ privacy and confidential information. ALP Sourcing will not take anything out of your facility during mock FDA inspectionsin order to keep your confidential information safe. We will not even write an audit report, because we are afraid of unintentionally disclosing your confidential information.
At the close of mock FDA inspections, we will discuss our findings with your management, from major concerns to minor ones, some of which may or may not appear on Form FDA-483, Inspectional Observations. During the closing session, we can also recommend corrective and preventive actions based on our past experiences with the United States Food and Drug Administration (US FDA). If you want us to conduct a review of your corrective and preventive actions after the close of the mock FDA inspections, then we are available via email as well as telephone, which allows you to avoid incurring expensive travel costs.