FDA Scolds New Jersey Devicemaker for CAPA Handling

January 4, 2019

The FDA hit Monmouth Junction, New Jersey device manufacturer Replication Medical with a Form 483 following an inspection that revealed issues with the firm’s documentation of corrective and preventive action activities and device history records.

The investigator, who inspected the facility between July 10 and August 22, 2018, found that the firm didn’t adequately document its CAPA activities and results. For example, the firm didn’t properly follow a complaint handling procedure and failed to routinely assess complaint trends, the agency found.

Additionally, a CAPA initiated in 2016 over an improperly installed water filter — which led to a broken water hose that flooded the facility — did not include a water sample test for total organic content despite the firm’s action plan requiring one.

Another CAPA was closed in February 2018 before a final quality control check could be conducted prior to packaging the firm’s one-piece posterior spinal implant product, GelFix, in foil. The CAPA was initiated in April 2017 when the firm discovered that three of its size 10 units had suture loops that were too small.

Some device history records showed that the firm exceeded drying times for GelFix implants by leaving them in the drying oven too long. Additionally, device history records for three lots of GelFix did not include documentation of labeling that the products were “For Export Only.”

The firm also changed the instructions for one of its devices but did not receive approval before establishing it. Instructions referred to as “NeuFx Lumbar Surgical Procedure” were updated to note that “only one or two turns is necessary to secure the holder.” However, the firm didn’t send the change through its document change request process as required.

Read the Replication Medical 483 here: www.fdanews.com/01-03-19-replicationmedicalinc483.pdf. — James Miessler

Classifying Complaints

Establishing a classification system for complaints helps organize your analysis. Quality expert Dan O’Leary of Ombu Enterprises recommends classifying complaints by type of failure. The real issue, he says, is that “a complaint alleges a deficiency.” The customer is complaining the device is deficient in meeting one or more essential design output areas, such as: identity; quality; durability; reliability; safety; effectiveness; and performance.

If you are going to use this classification method, O’Leary says, make sure your complaint SOPs clearly define each type and staff are trained to make decisions based on those definitions.

Devicemakers also could classify complaints according to source — written, electronic or oral message — O’Leary says, “but today this is not going to give you a lot of valuable information, because almost everything’s going to come in electronically.” This kind of classification can help manufacturers gain a better understanding of customer communication, however.

Ultimately, the devicemaker must make a key decision about each complaint. Does the complaint allege a serious incident — one that might have led or might lead to a death, a serious deterioration of someone’s state of health or a threat to public health?

If the answer is yes, the complaint must be reported to the FDA or other regulator based on their regulations.

If the complaint is determined to be “nonserious,” it does not need to be reported but it must be recorded, investigated and classified for analysis purposes.

It’s the way you use the results of this analysis that regulators emphasize. They want to know that you are tracking and identifying any significant increase in frequency or severity or other outlier uncovered in complaints and that you are using that information to make continual improvements.

Excerpted from the FDAnews management report: Complaint Management for Devicemakers — From Receiving and Investigating to Analyzing Trends.