483 Roundup: FDA Targets Four Device Facilities

The FDA has cited four device firms for a range of compliance issues including inadequate complaint procedures.

Following a November 2016 visit to Koros USA’s Moorpark, Calif., facility, FDA inspectors observed that the company had established inadequate complaint procedures. Specifically, the facility’s procedures did not include requirements to ensure that all complaints were evaluated to determine if an investigation was needed and whether the complaint was reportable. The procedures also failed to address; (2) any complaint involving the possible failure of a device, labeling, or packaging to meet its specifications was investigated; and (3) investigation records were maintained.

According to a Form 483, Koros also failed to update its written medical device reporting procedures to reflect current requirements for timeliness and for a standardized review process.

In addition, inspectors found that several of the company’s corrective and preventive action records were marked as effective, but there was no documentation to show how this was determined.

The company’s final inspection procedure did not include requirements to ensure that finished devices were not released for distribution until required activities were completed, until the associated data and documentation was reviewed, the release was authorized by a designated individual, and acceptance records were maintained.

Ascent Consumer Products: FDA inspectors visited Ascent Consumer Products’ Melville, N.Y., facility in November 2016 and observed that the company failed to make required reports and to provide other information relating to classification, safety, and effectiveness.

Specifically, Ascent did not evaluate the need to file information with FDA regarding the micro-filter squeeze product, which includes a filter intended to allow the use of potable water for nasal irrigation.

Ascent also failed to present adequate scientific evidence that the micro-filter squeeze product was safe and effective. In addition, it did not conduct studies to provide supporting data that the filter units had effective anti-microbial properties over the assigned expiration period when properly used, cleaned, and stored.

Vacumed: A facility belonging to Vacumed, a division of Vacumetrics, received a Form 483 following a visit from FDA inspectors in June 2016.

According to the Form 483, the facility’s procedures for design change were inadequate. Procedures failed to ensure that all design changes were validated, forms were not completed for design changes made to certain products, and documents were not handed in accordance with established procedures.

In addition, procedures for receiving, reviewing, and evaluating complaints by a formally designated unit were not adequately established. A complaint handling procedure failed to require an investigation of complaints involving possible failures in devices, labeling, or packaging. For example, certain devices were labeled and shipped incorrectly, but no investigation was conducted to ensure that appropriate corrective actions were implemented.

A.R. Hinkel: The FDA issued a Form 483 to A.R. Hinkel for failing to adequately validate design changes at its Chatsworth, Calif., facility.

The company’s procedures required documentation and approval of design changes through an Engineering Change Order Form, but it did not require that all design changes be validated.

For example, the electrical jacks on a device were redesigned to correct a problem involving electrical current delivery. However, no records were provided to show that this change was validated, reviewed, and approved. In addition, an Engineering Change Order Form was not initiated for this design change.

The companies did not return requests for comment.

Read the Form 483s here: www.fdanews.com/04-14-17-FourForm483s.pdf.