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Non-Clinical and Bioanalytical 483's
What is the Service? It is a subscription service that provides the content of recent FDA Form 483 observations for non-clinical and bioanalytical laboratory inspections by the FDA in the United States. You will receive periodic updates (about every 3 months) during the duration of your subscription. A one year subscription guarantees four deliveries.
How does it work? An individual may pay and receive a spreadsheet file containing transcribed individual Form 483 observations. To get a better idea, please review the example deliverable that is located on this website (note: the example is a .PDF file). The information is blinded as to the facility name and location that received the 483, and the individual 483 observations are listed in a searchable format.
What is a 483? A “483” is short-hand notation for an FDA Form 483 observation or objectionable practice. When the FDA inspects a facility and if there are any conditions or activities that do not meet FDA expectations or requirements, those deficiencies are noted on a Form 483 that is presented at the end of the inspection. The facility must make a written response with corrective actions or face follow up actions by the FDA.
Why are 483’s so important? Having access to 483’s is valuable for three reasons: 1) the product development timeline is so long that an organization may be propagating unacceptable practices through numerous activities before they ever get a visit from the FDA, 2) It can be difficult to predict if an organization’s specific practice or interpretation of acceptable procedure will indeed meet with the FDA’s approval, making it important to know if the FDA is citing other organizations for the same procedures or interpretations, and 3) having access to recent 483’s will give an individual a sense of what items the FDA is focusing its attention on currently.
Who would benefit from this information? This information is valuable to Quality Assurance, Operations, and Management. Quality Assurance (QA) often finds itself “leading the charge” at addressing new and changing regulations. Having access to current 483 observations can help frame the discussion on the need to change and how quickly to change. Operations has to stay current with the FDA requirements for procedures in the laboratory such as method validation, sample analysis, dose formulation and stability. It is vital to know how the FDA interprets its rules and the easiest way to do this is to see what practices it finds objectionable in others. Management needs this information because they are often forced to play arbitrator between the needs of QA and Operations. Important activities need to be prioritized, and having access to the specific 483 findings can help management decide what items need immediate addressment.
Aren’t 483’s readily available from the FDA? Yes and No. Yes, any form 483 is available from the FDA through the Freedom of Information Act (FOIA). All one has to do is to write to the FDA and request the Form 483 for an inspection of a specific facility on a specific date. There is usually a nominal charge for finding and copying the document and it can take from 1 to 3 months for fulfillment. No, because you would need to know what facilities were inspected and on what dates – a nearly impossible task.
Doesn’t the FDA list its inspections? Yes, the FDA maintains a list of inspected labs on its website, the Active Labs Inspection List. However, this list is not updated frequently and usually is 2 to 4 years out of date. This means that you could easily find facilities that were inspected in 2005, but won’t find any more recent inspections.
Why does there seem to be information missing? The FDA redacts (removes) infromation that is proprietary or could be considered confidential. Sometimes one word is redacted; sometimes whole paragraphs. Redactation is noted by "XXX" in the deliverable.
Why aren’t the facilities listed? The value of this service lies in the content of the 483 observations themselves, divorced from the information about the specific location and date of the observation. This information is meant to be used for the improvement of bioanalytical and non-clinical practices, not for gathering competitive information on other facilities.
If there is no date, how do I know they are current? All of the form 483 observations you will receive on your subscription are current; most of them are within the last 3-9 months. The reason for the range in dates is that there is variance in how long it takes the FDA to deliver requested information – some are delivered quickly (weeks) and some take longer (months). As information arrives from the FDA it is rolled into the next delivery package, regardless of the time frame of the actual inspection.
How do I know this is all there is? Actually, collecting information through the FOIA is a hit and miss proposition. It is very difficult to validate the information that is provided back. This makes it next to impossible to know what is missing. However, one thing is certain: the majority of relevant US inspection 483 observations are available through this service.
Why is Non-clinical and Bioanalytical presented together? The way that the FDA categorizes its inspections does not differentiate well between non-clinical animal operations and bioanalytical operations. In fact, there is a great degree of overlap and even some organizations perform both types of activities. This means that a 483 observation made at a non-clinical site may be valuable to someone in a bioanalytical operation, and vice versa. For this reason, these two types of activities are combined to provide the most value. No 483’s from Clinical or GMP operations are included.
How can I get earlier 483 information? An Archives Database is now avaialble. It contains over 350 individual 483 findings from 2008 through 2011. The Archives database can be ordered separately from the subscription service. Individuals who have a 2011 subscription receive a discount when purchasing the database.
How do you handle the redacted information? One of the most frustrating things about anything obtained through the FOIA is the redaction that occurs prior to delivery. Where information has been redacted from the 483 observation, three “x’s” (xxx) have been inserted into the text in the deliverable document. Most times the redaction does not affect the ability to interpret the observation, but there are cases where there is so much content redacted as to make the observation unintelligible.
What security and safeguards are in place? The .PDF files are secured with a password. You, as the subscriber do not have permission to print, modify, or edit the file, including copying text from the file to another source. Pharmaceutical Outsource Solutions, Inc. has invested money in procuring these observations and time in transcribing them, formatting them and providing commentary. We do not want people to misappropriate the material. During transcription of the actual 483 observations, certain systematic operations have been performed that will make most of the individual observations uniquely identifiable, and differentiate them from the exact 483 entries.
