FDA Inspections

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The US Food and Drug Administration (FDA) inspects regulated facilities to ensure their compliance with the laws and good manufacturing practice regulations surrounding the manufacture, labeling, and handling of food, drugs, medical devices, and cosmetics that are commercially distributed in the US. FDA inspections are conducted on both local and foreign establishments as long as the products are intended for US distribution.

Also, new drugs and biologics require FDA approval before they are introduced to the US market.

Types of FDA Inspections

The FDA prioritizes the inspection of companies that manufacture high risk drugs and equipment. Newly registered establishments and those that have past violations are also given priority for FDA inspections. Here are 4 types of FDA inspections that manufacturers can expect:

  • Pre-approval - an inspection that is conducted when there’s an application to market a new product;
  • Routine - the standard inspection conducted once every two years for domestic establishments and around once every 9 years for foreign facilities. If violations are found but corrective actions are immediately taken to address the issues while the FDA inspector is present, this will be noted as a positive indicator of the establishment’s commitment to stay compliant;
  • “For-cause” - an inspection intended to investigate issues or concerns that have been brought to the FDA’s attention; and
  • Compliance follow-up - if violations are found during an inspection, an FDA Form 483 will list the violations and the FDA will return to reinspect to confirm if corrective actions were taken to rectify the issues previously observed.

Inevitable but can be prepared for

FDA inspections are inevitable but you can prepare by proactively conducting regular internal audits so that compliance gaps can be found and immediately corrected. Conducting regular internal audits, however, can be time-consuming and tedious if the business is dependent on paper-based documentation. Proof of sound Good Manufacturing Practice (GMP) would require manually collecting and sorting through documents from multiple sources. Time spent on paper-based inspections and manual documentation could’ve been better spent correcting non-compliance before the actual FDA inspection happens.

iAuditor, the world’s #1 mobile inspection app, can help you conduct paperless internal audits and immediately assign tasks for urgent issues found. Check the current compliance status of your facility by tracking the overall trend of measurable audit results. Conveniently share information anytime anywhere and review historical data on one online platform.

To save you time, we have carefully collected and converted these free downloadable digital checklists you can use on the iAuditor mobile app to prepare for the FDA inspection:

5 Featured FDA Inspection Checklists

1. FDA Inspection: Preparedness Checklist

This FDA Inspection Preparation Checklist can be used to track the preparedness of a site or facility for an upcoming FDA inspection. Managers can use this as an aid to prepare the personnel, site, and documentation needed before an inspection. Use this as a guide for the following:

  1. Verify the preparedness of staff, facility, equipment, and all the relevant documents.
  2. Notify and assign tasks to the right colleagues who can work on areas or items needed for the FDA inspection.
  3. Identify red flags to help prioritize what still needs to be done.
  4. Measure the readiness of the facility using scoring.

2. FDA Inspection - Food Manufacturing GMP

This GMP audit checklist for food manufacturers can help determine how prepared is the manufacturing site for the FDA inspection. This checklist is based on 21 CFR Part 110 and can be used by site supervisors as a guide when conducting food manufacturing audits. Use this to:

  1. Assess the overall condition of the food manufacturing facility, the staff, equipment used, and food manufacturing processes.
  2. Conduct inspections on multiple sites/facilities and the results can be reviewed on an online platform.
  3. Share audit results via web link or as an attachment.

3. FDA Audit - Pharmaceutical GMP Checklist

This drug manufacturer audit checklist can be used to perform internal GMP audits for pharmaceutical manufacturing facilities. Operations managers can use this as a guide to measure the GMP compliance of the site. Inspect the facility and assess these six focus areas:

  1. General QA controls and procedures
  2. Facility controls and security
  3. Equipment design and placement
  4. Material component control
  5. Operational control
  6. Finished product control

This template was converted from ISPE GMP Audit Checklist for Drug Manufacturers. All iAuditor templates are fully customizable to fit your business needs.


4. FDA - Cosmetics GMP Audit Checklist

This GMP cosmetics checklist is based on the FDA’s GMP Cosmetic Guidelines. Use this to assess your manufacturing compliance with FDA guidelines. Facility managers can use this as a guide to:

  1. Inspect the facilities, equipment used, staff, raw materials, lab controls, record keeping, etc.
  2. Use the iAuditor mobile app to take photo evidence of non-compliance and can serve as reference for corrective action.

5. FDA - GMP Compliance Checklist

This General GMP Compliance audit checklist helps assesses the overall manufacturing practices and adherence to manufacturing protocols of manufacturing facilities. Operations managers can use this as an FDA inspection readiness checklist and help ensure that quality manufacturing standards are met. This can help with the following:

  1. Check the manufacturing site’s buildings and facilities, materials management, quality control systems, manufacturing, QMS, personnel, etc.
  2. Collect data and observe compliance trends on an online dashboard to better plan about improving good manufacturing practices.

Can't find the right checklist?

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Follow these 5 steps to start performing mobile inspections

  1. Create a free iAuditor account to get started
  2. Download a template above and modify it for your workplace or browse other checklist topics
  3. Install the iAuditor app on your mobile or tablet and perform an inspection
  4. Take photos, create actions and generate reports on your device
  5. Invite your teammates. Save time, save lives
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