During the first half of last year, FDA sent Warning Letters to companies across the medical device spectrum. Warning letters were issued to companies that sterilize medical devices including implantable joints and medical tubing; a specification developer that manufacturers a dialysate for hemodialysis; and the manufacturer of the HeartWare Ventricular Assist Device system.
Despite the substantial differences in the products and organization, a number of common quality violations were identified by FDA inspectors. The letters set the all-too-familiar stage, explaining, “… the methods used in, or the facilities of controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at title 21, Code of Federal Regulations (CFR), Part 820.”
A look at some of the Warning Letters identifies violations that may indicate FDA’s inspection priorities and thinking:
- Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements;
- Failure to establish and maintain procedures for validating the device design;
- Failure to establish and maintain procedures for implementing corrective an preventive action (CAPA);
- Failure to ensure that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or prevention of such problems;
- Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system;
- Failure to adequately establish and maintain the organizational structure to ensure that devices are produced in accordance with 21 CFR 820;
- Failure to adequately establish process control procedures that describe any process controls necessary to ensure conformance to specifications; and
- Failure to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.
Even a quick review of the violations contained in recent Warning Letters shows that FDA inspectors are scrutinizing multiple areas of operation, from production to receipt of supplies to management responsibilities to CAPA systems. Device manufacturers need to assess their own operations with the same comprehensive approach reflected in FDA’s recent Warning Letters.