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What are the most common FDA Form 483s inspection observations?

I recently had a couple of clients request a quotation for training on best practices for creating a design history file (DHF). Typically the most experienced quality managers request this training, even when they personally know a lot about design controls, because they know that the FDA issues a lot of FDA Form 483s against this requirement.

The most frequent category of FDA Form 483 inspection observation is design controls (i.e., 21 CFR 820.30). There are 10 different sections of the design controls requirement. Manufacturers that do not have design controls in place will frequently receive multiple observation findings during the same inspection–all related to design controls. The most common design control observations are:

  1. A procedure for design and development has not been established in accordance with 21 CFR 820.30a
  2. A procedure for design transfer has not been established in accordance with 21 CFR 820.30h
  3. A procedure for design changes has not been established in accordance with 21 CFR 820.30i
  4. A design history file (DHF) has not been established in accordance with 21 CFR 820.30j

Therefore, if a manufacturer has no procedure for design controls, then the manufacturer could receive 4 different observations on FDA Form 483.

ISO 13485:2016 Requirements

On March 1, 2016 the 2016 version of ISO 13485 was released. The new version of the Standard now requires procedures for design transfer, design changes and design and development files in an effort to be harmonized further with US regulatory requirements. Therefore, this presentation was created to specifically identify changes needed to your design controls procedure in order to comply with the latest version of the Standard.​​​​​​​

Design History File (DHF) Webinar

You can register for this live training webinar on April 14. For a cost of $129 you will receive:

  • a link to join the live webinar @ 10am EDT
  • a native slide deck for the new live webinar
  • a link to download a recording of the live webinar

This live webinar explains what needs to be included in your procedures for design and development, but the webinar explains how and when to create a design history file (DHF). After you create a procedure, you can show the recording of this webinar to your design and development team to ensure that design and development documentation is compliant and updates are efficiently maintained.

CLICK HERE to register for the DHF Webinar.

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