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FDA Compliance

Medical Device Manufacturers Warned for CAPA Noncompliance

FDA warning letters indicate the agency continues to be concerned about noncompliance

Published: Tuesday, August 1, 2017 - 12:01

Three recent warning letters from the Center for Device and Radiological Health (CDRH) offer a glimpse into ongoing medical-device inspection investigative focus. CAPA noncompliance is a top concern.

Inadequate corrective actions

An FDA investigation was conducted from January to February 2017 at a class II medical device manufacturer. The FDA laid out several concerns in its April 21, 2017, warning letter, noting areas of CAPA noncompliance.

Among other claims, the CDRH noted that CAPAs opened as far back as 2015 and 2016 did not have adequate corrective actions in compliance with the Title 21 CFR Part 820 Quality System (QS) Regulation.

A review of past responses determined that unsatisfactory corrective actions were taken in clean-room filling operations, and testing and validation of heat-seal integrity. In both cases, the medical device manufacturer closed its observations but failed to provide validation of why production did not need to be halted at that time.

Ignore CAPA at your own risk

As a result of the inspection, the FDA assigned a complete CAPA reexamination. The agency required that “effectiveness checks will be required for all medical device CAPAs, a retrospective review of closed CAPAs will be performed, and your firm will confirm that the risk score required by procedure is appropriate.”

Corrective actions must be based on hard evidence; documenting that a manufacturer hasn’t had any problems or complaints isn’t going to satisfy an inspection. For example, without adhering to detailed environmental monitoring outlined by ISO standards for cleanrooms, there is no acceptable rationale for declaring a cleanroom environment as “adequate.”

Unfortunately, as this case illustrates, having a CAPA process doesn’t necessarily mean that it is functional. If an operational, automated CAPA system were in place, clearly defined monitoring procedures and measurement criteria would ensure acceptable preventive actions were in place. Data would be collected and validated so any process would be repeatable and validated to ensure an occurrence (or reoccurrence) of a problem is avoided.

Incomplete CAPA processes

In a Feb. 23, 2017, warning letter, the FDA hit a Los Angeles-based manufacturer of digital X-ray image receptors and intraoral cameras for its own CAPA problems. For example, “...three out of three CAPA records reviewed failed to document an investigation. Two out of two CAPA records were reported as closed but failed to include verification or validation of the corrective actions.”

The letter also stated that the firm failed to establish medical device reporting (MDR) procedures, including failing to develop, maintain, and implement written MDR procedures.

Additionally, the medical device manufacturer failed to establish document control procedures as required by 21 CFR 820.40 (a). Thirty out of 30 procedures provided during the inspection had not been reviewed and approved.

CAPA noncompliance problems in Canada

Outside the United States, the FDA sent a warning letter to a Canada-based medical device manufacturer citing several CAPA noncompliance violations. The medical device manufacturer produces incline platform lifts, multi-lifts, and wheelchair accessible vans.

Following a February 2016 inspection of the Ontario facility, the FDA stated the company failed to establish adequate CAPA procedures. For example, CAPA procedures did not include requirements for key processes such as analyzing data to identify quality problems, validating CAPAs to ensure their effectiveness, and recording procedural changes to correct and prevent defects. In addition, certain CAPAs were not documented before they were closed.

Failure to validate a CAPA or record changes in procedure provides no assurance that an action was effective for reducing risk. Furthermore, if changes aren’t documented electronically, those directly responsible for product quality might not even be aware of these problems. However, they can be held liable for future adverse incidents.


FDA warning letters to medical device manufacturers continue to offer convincing evidence that CAPA noncompliance remains a top concern. World-class medical device manufacturers view it as the foundation for strong and compliant operations. The solution is to control unstructured and undocumented quality issues in an electronic quality management platform. Corrective and preventive actions, MDR procedures, document control, reviews, and approvals move seamlessly through workflows and are captured in a closed-loop system.


About The Author

AssurX’s picture


AssurX Inc. develops quality management and regulatory compliance software solutions to help companies in any industry exceed quality expectations, ensure compliance, manage risks, and better govern their enterprise. AssurX solutions securely handle manufacturing defects, complaints, change control, regulatory compliance, supplier quality, audits, risk, corrective and preventive actions, and more.