Top Five 483 Observations for Medical Devices

At the June 5, 2012, Association of Food and Drug Officials Meeting in Providence, Rhode Island, Regina Barrell from FDA’s Office of Enforcement presented the top five 483 observations for medical device companies for 2011. The citations were taken from FDA’s Turbo database in which all 483 citations are entered. The top five regulatory provisions under which FDA issued the most 483 observations are:

820.100(a) – Corrective and Preventive Action Procedures

820.198(a) – Complaint Procedures

803.17 – Written MDR Procedures

820.100(b) – Corrective and Preventive Action (Documentation)

820.75(a) – Process Validation

The FDA guidance, Inspection of Medical Devices  Program 7382.845, explains the procedures that FDA investigators are expected to follow during inspections of medical device companies.  There are two types of inspections:

1. The most comprehensive inspection is a Level 2 inspection. This covers all of the major quality subsystems including management controls, design controls, production and process control and corrective and preventive actions, “CAPA” (which encompasses MDRs, correction and removals and tracking, if applicable).

2. An abbreviated inspection is a Level 1 inspection. This covers CAPA and one of the other major subsystems mentioned above.

FDA has limited resources and most inspections are Level 1 inspections. Thus it is not surprising that the CAPA subsystem and the associated feeders to the CAPA subsystems (complaints and MDRs) are included in the top five observations.

To help companies understand how FDA investigators interpreted companies’ failure to meet the top five regulatory requirements, Ms. Barrell gave concrete examples of what investigators found under each category of the citations.

Number One: 21 CFR 820.100(a)

21 CFR 20.100(a) requires that procedures for corrective and preventive action be established.  Deficiencies that investigators found under this provision is that companies failed to analyze processes, service records, quality audit reports, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product. Other deficiencies include companies failing to correct and prevent recurrence of nonconforming product; failing to identify other quality problems; or failing to investigate the causes of nonconformity relating to both the product and processes.

Number Two: 21 CFR 820.198(a)

21 CFR 820.198(a) requires that companies establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Under this provision companies are cited for failing to process their complaints in a uniform or timely manner; failing to fully document their complaints; or failing to evaluate complaints to determine if they have to report the incident under the MDR requirements.

Number Three: 21 CFR 803.17

21 CFR 803.17 requires that companies develop, maintain and implement written MDR procedures. Under this provision companies are often cited for failing to have their complaint handling procedures include a description for how their complaints will be reviewed for MDR reportability and actually filing the required MDR reports.

Number Four: 21 CFR 820.100(b)

21 CFR 820.100(b) requires that companies adequately document their corrective and preventive action activities and/or results.  Under this citation companies may have taken corrective and preventive action, but often times they fail to maintain the required documentation.

Number Five: 21 CFR 820.75(a)

21 CFR 820.75(a) requires that companies validate processes whose results cannot be fully verified by subsequent inspection and test. Under this provision, FDA investigators cite companies for failing to validate processes they use when they manufacture of their products.

Companies wanting further guidance on the types of observations that investigators will cite for failure to comply with a specific subsection of the Quality System Regulation can go to the FDA warning letter data base

The data base allows companies to search for warning letters issued to:

- A specific company, - By a specific district, or - Under a specific regulatory provision.   Companies can use the information gleaned from the data base to avoid making mistakes similar to the ones cited in warning letters and maintain regulatory compliance.

* This article was co-written by Nancy Singer and Mark Laguniwich. Nancy Singer is President of Compliance-Alliance, LLC. Mark Lagunowich is Director of Sales with Sparta Systems

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