This blog is a summary of the most frequent observations of the FDA to the medical device companies during the fiscal year 2017.
The fiscal year of the FDA is the period between October 1 and September 30 of the following year.
The FDA's observations are known as "483's," since this is the form the FDA inspector uses to report the observations to the manufacturer.
The FDA recently published (www.fda.com) its annual summary of 483's for FY 2017. This information is important because it allows us to identify possible areas of focus of the FDA during the inspections, and allowing us to verify if we are in compliance with the regulations.
Corrective and Preventive Actions: 515 Observations
It’s not surprising to find “Corrective and Preventive Actions" heading the list of the most frequent observations. In the last five years, CAPA has been consistently one of the elements of regulation that receives more 483's during FDA inspections.
According to the QSIT (FDA Quality Systems Inspection Technique), CAPA is one of the 4 major subsystems of the quality system:
During a comprehensive inspection each of these subsystems must be investigated; and during an abbreviated inspection, two major sub-systems must be investigated: CAPA and Design Control, or CAPA and Production & Process Controls (P&PC). For this reason, the CAPA process is always investigated during an FDA inspection.
21 CFR 820.198 (a) Complaint Records: 323 Observations
Complaints records have also historically been among the most cited 483's by the FDA.
The FDA requires that medical device companies promptly investigate complaints from the market and document the entire complaint handling process in detail.
For this reason, companies must keep records of complaints received and implement procedures to receive, review and evaluate complaints. The evaluation of the complaint allows companies to determine if due to the potential harm to the patient, the complaint is an event that must be reported to the FDA.
21 CFR 820.75 Process Validation: 165 Observations
Process validation is one of the elements of the "Production and Process Controls" QSIT subsystem.
As we explained earlier, this subsystem will always be investigated during a comprehensive inspection of a medical device manufacturer.
Validating the process means establishing, through objective evidence, that the process produces a product that complies with the specifications in a consistent manner.
A poor process validation does not provide the confidence that the product has the required quality or that the product is safe for the patient.
21 CFR 820.30 (g) Design Validation: 164 Observations
"Design Controls" is another one of the main subsystems of the QSIT. Design validation must ensure that the devices meet the patient's needs.
To validate the device design, initial production units (not prototypes or test runs) must be used. These units must be simulated or tested under real conditions of use, whenever possible.
If the device has software, FDA requires that design validation also includes software validation.
21 CFR 820.90 (a) Non-conforming Product: 161 Observations
The handling of a non-conforming product is critical in the medical device industry: a defective product in the market can cause a patient harm or even death.
It is important to remember that according to FDA’s definition, the term "product" refers to manufacturing materials, components, product in process, and finished product.
Some of the requirements for the handling of a non-conforming product are the identification and segregation of the product, to prevent the manufacturer from sending it to the market by mistake.
Author: Vanessa Rival, Quality Systems and Regulatory Compliance Manager at Precision Concepts Costa Rica