Inspection Observations - FDA.gov

Go to this FDA webpage:  Inspections > Inspection Observations - FDA.gov:

"FDA’s Office of Regulatory Affairs (ORA) is the lead office for all field activities, including inspections and enforcement. During an inspection, ORA investigators may observe conditions they deem to be objectionable. These observations, are listed on an FDA Form 483 when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA’s requirements.

Spreadsheets summarizing the areas of regulation cited on FDA's system-generated 483s are available by fiscal year on the menu links on this page. These spreadsheets are not a comprehensive listing of all inspectional observations but represent the area of regulation and the number of times it was cited as an observation on an FDA Form 483 during inspections conducted by FDA and its representatives. Turbo EIR is FDA's automated Form 483 reporting system. Turbo EIR is utilized to generate the FDA Form 483 when applicable cite modules exist. Not all FDA Form 483s are generated in TurboEIR as some 483s are manually prepared and not available in this format. Observations have been broken out by Product or Program Area on separate tabs of the spreadsheet. The Product and Program Areas include the following:

• Biologics
• Drugs
• Devices
• Human Tissue for Transplantation
• Radiological Health
• Parts 1240 and 1250"

'via Blog this'

In fiscal year 2014, you'll notice that biologics and drugs areas were highly associated with some kind of sub-standard investigation.

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FDA Webinar on FDA Inspection Process

When:     Thursday, March 25, 2010, at 2 p.m. ET

Where:    https://collaboration.fda.gov/inspectionprocess/

Host:       FDA’s Office of Regulatory Affairs (ORA), 301-827-3101

             ORAContactUs@FDA.HHS.GOV

Speaker: Michael C. Rogers, deputy director, Office of Regional Operations

To ensure the safety of marketed products, FDA experts inspect domestic and foreign establishments, check shipments of imported products, and collect and test product samples for signs of contamination.

During this webinar, FDA experts will present information on

• the organization within FDA that is charged with conducting inspections
• the facilities FDA is responsible for inspecting
• what an inspection involves
• inspection follow-up and enforcement actions
• the rigorous training that inspectors receive

The presentation will run approximately 30 minutes and will include an opportunity to ask questions.

To join the webinar:

1. Click https://collaboration.fda.gov/inspectionprocess/ (or cut and paste it into your Internet browser)
2. Click "Enter as a Guest," fill in your name, then click "Enter Room"
3. Dial 1-877-685-5350 and enter participant passcode: 969082

You might also be interested in:

Surviving an FDA Inspection - a training course by SkillsPlus International Inc.

This class prepares plant personnel to participate in an FDA Inspection.

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FDA 483 Inspectional Observations - learn from these examples

• FDA cGMP QSR GMP Online Training - respected cGMP online training classes offered by SkillsPlus International Inc.

Here's a small collection of 483s (FDA Form 483 Inspectional Observations). If you've never seen one before, here's your chance. Take advantage of these to learn and share, so that you can avoid getting your own 483s. You can view these on the FDA's website, in the FDA Office of Regulatory Affairs (ORA) Electronic Reading Room. They display copies of ORA records. ORA makes these records publicly available either (1) proactively at their discretion or (2) because they are "frequently requested" per the Electronic Freedom of Information Act Amendments of 1996. Some records may be redacted to remove non-public information.

According to GMP Trends Inc., "an FDA 483 is a form used by an FDA investigator following an inspection of your plant. It lists deficiencies in your quality system and potential non-compliance issues with GMP's. These observations are based on the investigators interpretation of the GMP regulations as they apply to your specific situation. During the investigator's closing meeting with management, you may be given a Form 483." You can learn more about the FDA's thinking on 483s by reading this section from one of their manuals, FDA Investigations Manual - Reports of Observations.

These 483s can do several things for you. They'll:

1. Get you more familiar with what a 483 is all about
2. Give you the willies so you'll never want to earn your own 483s
3. Provide examples that you can incorporate into your GMP training efforts

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