How Often Does FDA Flag CAPA Flaws in 483s and Warning Letters?
May 31st, 2025 // 8:01 pm @ jmpickett
FDA recently issued five warning letters to medtech companies for falling short on cGMPs under the QS regulations. The most common issue raised by FDAers were the companies’ failure to implement CAPAs.
On Jan. 14, 2025, FDA published five warning letters to Hologic, Integra Lifesciences, Randox Laboratories, Xoran Technologies, and Phillips Precision. The agency found flaws in the manufacturing facilities for each company. The warning letters addressed issues such as not meeting device control procedures, medical device validation, CAPA requirements, and acceptance procedures.
In a warning letter dated December 19, FDA told Hologic that it failed to establish/maintain procedures for CAPAs, such as protocols for analyzing processes, concessions, work operations, quality records, complaints, returned products, and quality auidt reports, using accepted statistical methodology.
The medical device company had already withdrawn products from the market and answered a 483 about the flaws. But FDA noted the company’s actions were insufficient. FDA stated that the company didn’t calculate how common adverse events were related to the BioZorb implanable radiographic markers because it didn’t account for the patient population, and it was more concerned about not following up on design studies to find how the device affects patients who already have the device implanted.
For Integra, FDA stated that the company didn’t follow CAPA procedures at some facilities, and results from updated CAPA efforts cannot be checked until the end of 2025. FDA said in its warning nletter that a quality data shources review over Integra sites, including quality plans and CAPAs showed that site specific CAPAs weren’t evaluated for escalation to CAPAs for the entire company. For instance, FDA said that a CAPA was started in April 2023 because of findings from an endotoxin test at one facility, but Integra didn’t offer justification for not escalating the CAPA to the whole company.
What The FDA Data Shows About CAPAs
So, we know that FDA has issued a bunch of warning letters about CAPAs this year alone. How common is this observation? A review of FDA data reveals that FDA often issues 483s and warning letters for flaws in CAPAs because they are a vital part of QS regulations under 21 CFR Part 820.100 for medical devices, as well as 21 CFR Part 211 for drugs.
Data between 2010 and 2023 show that CAPA-related observations were usually the #1 reason for FDA 483 observations in the device industry. Every year from 2010-2016, FDA stressed CAPAs as the top observation. The most common citation was for lack of or inadequate CAPA procedures.
In 2021, design input documentation, design control, and risk analysis flaws were some of the top causes of 483s. All of these observations are closely related to CAPAs.
Further, FDA data reveals that at least 75% of FDA warning letters with QS observations between 2010-2014 had CAPA violations.
FDA performed between 2400 and 3400 medical device inspections annually from 2009-2014. Many of them led to 483s and CAPA problems were noted in a large fraction of them. Common observations were lack of root cause analysis, not documenting CAPA plans, or inadequatae preventive actions.
FDA data for 2022 and 2023 shows that the agency issued 47 warning letters to drug manufacturers, and many noted CAPA issues. For example, warning letters to Edge Biologicals and Baxter Healthcare Corp. cited not conducting prompt investigations and implementing proper CAPAs.
Taking Action For CAPA Flaws
One of the most common issues with CAPAs that gets companies in FDA hot water is a complex or ill-defined CAPA process. A company may try to acount for all possible incidents or exceptions, making every one part of the CAPA process. But this can make the CAPA process too complicated because it’s too confusing for company stakeholders to follow.
Processes and systems need to be devised in a way that they support the employees who must handle the CAPA mission for the company. If they are too complex and confusing, employees won’t buy in, and the process won’t be followed.
On the other hand, CAPA processes can be too vague, triggering uncertainty about the steps that stakeholders should take, and inconsistency occurs in how the steps are followed. A well-designed CAPA system will feature an escaliation process that can handle rare incidents or unexpected issues.
Next, many companies’ CAPA processes don’t have enough documentation. A good CAPA process has ample documentation at all process stages. Employees should be able to access tools that simplify the documentation process and streamline information gathering. Many mobile apps are available today that support fast input that encourage this process. Remember, simplicity is critical. If the CAPA process is easy to follow, it’s more likely that your team will gather clear, complete documentation of each CAPA.
