Note: The data provided in this post was gathered in July 2023.
There are some significant limitations to the FDA Data Dashboard, however. The number and types of records and documents it has is limited. It lacks sophisticated alerting and trending analytics.
In order to prepare for inspections and to better manage risk with vendors and in Contract Manufacturing Organizations (CMOs), today’s quality and regulatory professionals in life sciences companies require additional data, enrichment, and analytics to be effective in their roles.
Read on to discover how Redica Systems builds on FDA’s data to provide actionable quality and regulatory intelligence on inspection trends and much more.
Redica Systems Has More Data and Powerful Analytics
The following charts demonstrate how Redica Systems offers data – and, more importantly, insights – beyond what is available on the FDA website.
On the FDA Dashboard, inspection records are incomplete, only going back 13 years. Often, GCP, mutual recognition agreement (MRA), MDSAP, and state inspections are left out. With three-fold more inspection reports, Redica Systems’ inspection records collection is a more robust data set that provides a more complete view of inspection activity and the deficiencies found, which in turn produces better trending and decision-making.
The user interface of the FDA Data Dashboard, as well as the CDER FOIA Electronic Reading Room and the ORA FOIA Electronic Reading Room, which are separate databases, are also quite limited.
The CDER FOIA Electronic Reading Room has a search function only. No filter function.
The ORA FOIA Electronic Reading Room has a search function and a filter function.
None of them has the ability to link related documents together. Yet that’s where most of the insights to be gleaned come from. For example, imagine that a particular site gets inspected by FDA and receives a 483, followed by a Warning Letter sometime later.
Which organization operates that site? Which sponsors does that site supply? What drugs does that site play a manufacturing role in? Is the site making APIs, excipients, or FDF? What was cited in the 483 and the Warning Letter? Which Quality Systems are those citations associated with? Which inspector visited the site and issued the 483? What do they tend to cite most often across their recent inspections?
The answers to these questions yield valuable insights, but to get these answers, you need something more robust than the various FDA databases.
In comparison, Redica Systems is the No. 1 FOIA requester of FDA inspections, capturing and saving all published and unpublished inspections from the agency. Some records even go back to 1977 (get out your disco attire!).
On the FDA Dashboard, documents are incomplete and not searchable.
In comparison, Redica Systems is the No. 1 requester of FDA documents. These documents are then converted to fully searchable text.
While the 483s are valuable, at Redica Systems, we also have a collection of responses to the 483s, which provide an additional level of insight: when a company receives a 483 observation, how does it respond? When a 483 is available along with the company response, and if the responses did not meet the threshold of what FDA expected and a warning letter results, that chain of documents provides an invaluable level of insight into the deficiencies uncovered during an inspection and the agency’s expectations.
Text 483 Observations Comparison
On the FDA Dashboard, searchable text of individual 483 observations is not available.
In comparison, Redica Systems provides optical character recognition of all 483 text and a team retypes and cleans the individual 483 observations. Why is this step important? To find anything in a 483, it must be text searchable. While a human can read the text in a scanned picture file, a machine cannot – the common <control><f> to find a word or phrase simply does not work. And retyping and cleaning the text ensures there are no typos or misspellings, which, if present, can prevent finding the word or phrase being searched for.
On the FDA Dashboard, inspection records are incomplete, only going back 13 years, and often do not include GCP inspections, MRA, State Inspections, Clinics, and MDSAP inspections.
In comparison, Redica Systems captures and saves all published and non-published inspections from the FDA, going back to 2000. The more complete a collection of citations is, the more reliable and valuable trending and analysis based on those data become. Examining trends can give insight into the direction regulatory agencies and enforcement activities are moving.
On the FDA Dashboard, the inspection reason is not provided.
In comparison, Redica Systems includes inspection reasons (for-cause, preapproval, and remote) for most inspections conducted since 2010.
Why is this information valuable?
While routine or surveillance inspections are just that, routine and done periodically, those are the most common inspection type and result in the largest share of inspection observations. However, agency resources do not always permit parity of inspections between companies, and it can be instructive to find out when those inspections took place and how recently the last inspection was at a particular facility.
For-cause inspections, however, are triggered when the agency has reason to believe a facility has serious manufacturing problems or to investigate a problem or complaint – for example, high-profile recalls, customer complaints, or whistleblower accusations. In any case, a for-cause inspection deserves the attention of pharma companies who are doing business with the inspected company or considering it. Putting inspection findings in the context of the inspection type can facilitate interpretation of the deficiencies found.
FDA Investigator Resumes
On the FDA Dashboard, Investigator names are not included with inspection records
In comparison, Redica Systems includes FDA Investigator resumes and full profiles of active and former FDA Investigators since 2000.
FDA investigators tend to focus on areas that match their expertise and experience, and as with any scientific professional, each has his or her own views of which areas are the most important or which ones are more prone to error or deserve more scrutiny.
Redica’s investigator profiles include accumulated data from 483s and EIRs providing detailed histories and analyses showing by quality system the frequency of observations given, how often an inspection results in a 483, and how often a 483 is followed by a warning letter. Knowing when an FDA investigator shows up at your facility which areas tend to get the most scrutiny can be invaluable information.
A World of Data
But Redica provides more than FDA data. The platform also offers access to inspection findings conducted by EMA, UK MHRA, Health Canada, and the U.S. Department of Agriculture (USDA). Redica is the top FOIA requester for multiple global agencies.
Pharma companies operate in a global marketplace, and inspections by health authorities from Europe, Canada, and beyond are important for compliance and approval in the markets they regulate. If a company is seeking a partner in Europe, for example, knowing whether that firm has received a GMP Certificate or reports of non-compliance from EMA is a key part of due diligence.
In the U.S., in addition to the FDA, the USDA also regulates some aspects of drug manufacturing – for example, its Center for Veterinary Biologics regulates animal vaccine production. FDA’s dashboard does not contain USDA information.
Additionally, Redica enriches the data by mapping out relationships among parent companies, subsidiaries, and suppliers into family trees for the top pharma and med tech companies. Deficiencies addressed in 483 observations and Warning Letters are also organized by quality system category.
Redica Systems has developed a Quality System Labeling (QSL) model that maps inspection observations not only to FDA’s six quality systems but includes Data Integrity as a seventh quality system and drill down within each quality system two or three levels deep to reveal the specific deficiency that caused the 483 observation (see below).
We have also developed a risk algorithm we call the Red Flag Model that rates and ranks the relative risks of inspection observations and other factors to provide a graphic representation of the potential risk position of the firm in question from a quality perspective.
Organization and site profiles provide instant access to enforcement histories for specific organizations and sites. Redica has over 200,000 organization and 250,000 site profiles with complete inspectional and enforcement history and benchmarks to industry averages. Customers can also receive email alerts when an organization or site is inspected or receives an enforcement action.
When compared to the FDA website, Redica offers 1,000% more data that is enriched and mapped to quality systems. This information is made searchable and includes profiles for investigators, sites, and organizations and augmented with non-FDA data.
To further see how Redica compares to FDA, contact us for a walkthrough of the platform and see where we can take you.
Subscribe to Redica Insights
Get quality and compliance insights from our experts in your inbox