Bernafon-MAICO Inc.

Bernafon-MAICO Inc. 5/06/97

3. Software revisions have been made without Engineering Change Order (ECO) control, resulting in the distribution of audiometers with unapproved software. ECOs do not include a record of software source code changes and obsolete versions are not archived [21 CFR Part 820.100 (a)(2)]. Software source code is not controlled under the document control system (21 CFR Part 820.80).

In legal terms, the products are adulterated under Section 501(h) of the Act.

The specific violations noted in this letter and in the FDA-483 issued at the close-out of the inspection (copy enclosed) may be symptomatic of serious underlying problems in your firm’s manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by the FDA. If the causes are determined to be systems problems, you must promptly initiate permanent corrective actions.

It should be noted that the items regarding software documentation and change, inadequate failure investigations; and identification of complaints when screening repair and service requests were cited on the form FDA-483, Inspectional Observations, that was issued at the close of the previous inspection of your firm on April 24, 1995. Your Engineering Manager, xxxx, participated in the discussions of the items on both the previous and current FDA-483s.

Thank you for your April 29, 1997, response to our FDA-483, Inspectional Observations form, dated April 14, 1997.

Your responses to the concerns referenced in the FDA-483 are noted and are being made part of the official file. The corrective actions that you are taking are appropriate for addressing most of the concerns raised during the April 1997 inspection. However, your response does not address the issue of lack of validation for changes that have already been made to the software (item #5 on the FDA-483). During the next inspection, we will assess the effectiveness of the implementation of the corrective measures that you reference in your letter.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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