Handling Complaints according to 21 CFR 820.198(a)

The FDA sends out a great proportion of the FDA-483 documents because a company has failed to adequately receive, review and evaluate complaints sent to them by customers or other persons of interest. In 2010, for example, there were FDA citations about complaint handling more than 300 times. Of those 100 deficiencies were felt to come from drug manufacturers, while 200 deficiencies were found in device companies.

Because of these ongoing warning letters, it is clear that companies need to have a solid schema in place to handle complaints as directed in the 21 CFR 820.198(a). What’s needed is information that details the best practices for establishing the nature of a complaint and for maintaining complaint-handling systems that are within compliance.

Things you should know include:

– Which areas are most troublesome in complaint handling systems?

– How do you adequately investigate a claim?

– Is the complaint system you have adequate for the FDA?

– What is a timely period of time in order to completely investigate and close a claim?

– Is a service request for your product considered a complaint?

– What should you do if you get a reportable complaint about another company?

– What documents are necessary if you believe the complaint doesn’t warrant an investigation?

– When should you contact the user when following up on a complaint?

– Can you motivate other departments to be thorough about complaints investigations?

– Is there a specific FDA-approved method of complaint trending?

– What aspects of complaint trending the management should look after?

– When is a complaint considered closed?

– How long do you have before you need to close a complaint?

The FDA document 21 CFR 820.198(a) is one that specifically provides information on how to handle complaints. According to the FDA, each manufacturer of pharmaceuticals or devices must maintain files regarding complaints it receives. The company must also have procedures for receiving, reviewing and evaluating complaints by means of a formally designated person, whose job it is to handle all complaints from beginning to end and make sure all complaints are handled in a timely and uniform manner.

If a complaint is made orally, it needs to be documented upon receipt of the complaint and treated as a written complaint. Following the receipt of a complaint, the complaint is evaluated to determine if it is a complaint that must be reported to the FDA. This might be required under the guidelines listed under 21 CFR 820 part 803, listed as “medical device reporting”.

The manufacturer’s complaint team must review and evaluate the nature of all complaints to determine whether or not an investigation is needed. When no investigation is warranted, the manufacturer must still maintain a record of the complaint that includes the reason behind not doing an investigation and it must include the name of the person who made the decision that no investigation was necessary.

If the complaint dealt with a mislabeling event, packaging error or failure of a specific device, it must be reviewed, investigated, and evaluated by the investigation team unless a similar error has already been investigated so that this investigation would be a duplication of work.

If you, as a team, decide that the complaint must be reported to the FDA under part 803 of CFR 820, it must be promptly reviewed and investigated by designated persons and a separate report must be made according to the information given in section 820.198(e) and this designated team needs to determine whether or not the device failed to meet specifications, whether the device was used for patient treatment or diagnosis, and the relationship that may have existed between the device failure and an adverse event on the part of the patient.

If a device is investigated that needed a report to the FDA, the record of the investigation must include the device’s name, the date of the receipt of the complaint, control numbers or device identifications (if used), the information regarding the name, address and phone number of the person who made the complaint, the nature of the complaint, including details of what happened, the dates and results of the team’s investigation, whether or not corrective action was taken and whether a reply was sent back to the complainant.

If the complaint team and investigation of complaints is not done at the site of manufacture, the records of the complaint assessment need to be readily accessible to those who do the manufacturing of the item. If the complaint team operates outside of the US, the records still need to be readily available within the US at a special location where the manufacturer’s records are normally kept or at the location of the initial distributor.

Members of the team doing the receipt, evaluation and investigation of the item involved in the complaint need to be known by the FDA should questions arise.

Regulatory Affairs Associates (RAA) can help you with these complaints and the forms involved with this law. Call Stephen Goldner JD RAC, President and CEO, at 248 747 8008.

The author is a family practice MD. http://www.regaffairs.com

The author is a family practice MD. http://www.regaffairs.com

Author Bio: The author is a family practice MD. http://www.regaffairs.com

Category: Medical Business
Keywords: FDA consultants, Regulatory Affairs Associates, FDA complaints