Devicemakers preparing for an FDA inspection should pay attention to their corrective and preventive action (CAPA) procedures, according to an FDAnews analysis of recent FDA warning letters.
The review of 10 warning letters sent to devicemakers shows CAPA problems were cited 18 times. These problems involved a failure to maintain or document CAPA procedures.
For biologic devices, CAPA procedures also tops the list of observations, along with problems for nonconforming products, contamination control and complaints. CAPA isn’t the top concern — internal investigations holds this prize — for drug and biologics manufacturers, but that doesn’t mean it shouldn’t be a priority.
The first step companies should take to prepare for an inspection is to study recent warning letters and note what responses the FDA has considered inadequate, attorney Cathy Burgess of the Washington, D.C., law firm Crowell & Moring said at an FDAnews audioconference.
FDA auditors always review CAPA (21 CFR 820.100) systems during inspections, according to Kim Trautman, CDRH’s good manufacturing practice (GMP) expert. Since many inspectors audit both device and drug companies, they tend to place more emphasis on CAPA or production and process controls as auditors are more comfortable reviewing them for both types of inspections, Trautman told FDAnews.
Tim Ulatowski, director of CDRH’s Office of Compliance, agreed. “It’s not unusual to see more CAPA violations. It’s the nature of our QSIT program to investigate those types of issues,” he told D&DL, referring to the FDA’s Quality System Inspection Technique (QSIT).
QSIT uses a “top-down” approach that advises inspectors to examine companies’ systems used for addressing quality before they look for specific quality problems. It contains four targeted subsystems that include CAPA, management control, design controls and production and process controls, according to the FDA’s Guide to Inspections of Quality Systems.
One of the most commonly observed CAPA issues cited in the 10 warning letters FDAnews analyzed was violation of 21 CFR 820.100(a)(3), which includes requirements for “identifying the action(s) needed to correct and prevent recurrence of non-conforming product and other quality problems.” For example, Haemonetics was cited for this violation when it told the FDA it had revised some of its documents but didn’t submit the documents for the agency to review.
With 11 citations, the second most frequent category of violations was maintenance of complaint files (21 CFR 820.198). Some companies, such as I-Flow Corp., did not ensure that complaints of device failures were reviewed and investigated (21 CFR 820.198(c)). After customers complained of faulty infusion pumps, I-Flow confirmed that the devices had malfunctioned without investigating the root causes of the malfunctions, according to the warning letter.
Design control (21 CFR 820.30) issues were referenced seven times, making them the third most common category in the warning letters, issued between Nov. 1, 2008 and Jan. 31, 2009.
Problems with design changes (21 CFR 820.30(i)) were particularly frequent. For instance, Innovative Neurotronics updated its standard operating procedures for design changes without distinguishing the difference between what it considered “temporary deviations” and “deviations,” a warning letter says.
Tied in frequency with design controls were observations related to process validation (21 CFR 820.75). One example is Contract Medical Manufacturing (CMM), a supplier of custom cranial implants for Stryker. CMM failed to demonstrate that its personnel had validated its sterilization processes, the warning letter says. Stryker recalled the implants because their sterility could not be guaranteed.
Other categories frequently noted in the letters included acceptance activities (21 CFR 820.80) and management responsibility (21 CFR 820.20), which were each cited six times. Purchasing controls (21 CFR 820.50) were referenced five times, and four citations involved nonconforming product.
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