Design changes snare 4 device firms; one cited for not doing risk analysis.FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. poured on the warning letters to device manufacturers this past month, citing four companies for making changes to products without design controls and in one case, slapping slapping, n massage technique that uses the flat palms of the hands percussively; a form of tapotement. See also tapotement. a Canadian firm for not doing risk analysis, which is one of the hallmarks of the 1996 Quality Systems regulation. Inovo of Naples, FL, was cited in a recently released June 6 warning letter for "work instructions, drawings, process travelers [that] do not accurately reflect the design of the oxygen-conserving pressure regulator A Pressure regulator is a valve that automatically cuts off the flow of a liquid or gas at a certain pressure, usually for the purpose of preventing damage to plumbing. Pressure regulators are often used at the main entrance of water to a building. device manufactured under contract." Florida district inspector Michelle Dunaway's May 8-24 audit also uncovered enough information to lead to a citation Citation (foaled 1945) U.S. Thoroughbred racehorse. In four seasons he won 32 of 45 races, finished second in ten, and third in two. He won the 1948 Triple Crown, and became the first horse to win $1 million. He set a world record in 1950 by running a mile in 1:33 3/5. for failure to establish and maintain procedures for approval and implementation of design changes for contract-manufactured devices. The agency cited Inovo for a variety of quality control problems, including a failure on the part of management to "ensure that the quality system is adequate and effective." No comment from the firm was available before deadline. Doc. 9144W Risk analysis for convenience kits slapped Failure to include risk analysis in design controls snared Winnipeg, Manitoba-based National Healthcare Manufacturing Corp. (NHMC NHMC National Hispanic Media Coalition ). The April 4-6 inspection of the firm, which makes convenience kits, also disclosed that NHMC had substituted a header (1) In a disk or tape file, a set of data that resides permanently at the beginning. It may be used for identification only (type of file, date of last update, etc.), or it may describe the structural layout of the contents, as is common with many document and database formats. bag for an unnamed device(s) and/or component(s) without "approval prior to implementation." The unnamed investigator also complained that the firm's device master records failed to document any procedure for determining expiration dates Expiration Date The day on which an options or futures contract is no longer valid and, therefore, ceases to exist. Notes: The expiration date for all listed stock options in the U.S. . The warning letter made no note of a company response to the 483 or of any intent to detain de·tain tr.v. de·tained, de·tain·ing, de·tains 1. To keep from proceeding; delay or retard. 2. To keep in custody or temporary confinement: the company's products. No comment from the company was available before deadline. Doc. 9301W Investigator Ronald Weber of the Florida district audited Omega Medical Imaging's plant in Sanford, FL, and came up with a failure to "establish and maintain a design change procedure." The warning letter did not go into detail regarding this deviation. The July 11-12 inspection disclosed that Omega "failed to exercise management responsibility to ensure that the quality system is adequate and effective" and noted that while the maker of cardiac and vascular imaging system had a procedure for internal audits, it had nonetheless "failed to do so." The warning letter also zapped Omega for lack of procedures for "identifying, reviewing and analyzing nonconforming product or other quality problems." FDA advised the company that its July 14 letter in response to the 483 was "inadequate because it fails to provide any descriptions of your planned corrective actions A corrective action is a change implemented to address a weakness identified in a management system. Normally corrective actions are instigated in response to a customer complaint, abnormal levels if internal nonconformity, nonconformities identified during an internal audit or and the documentation covering those actions." Robert Lindquist, the newly-appointed President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , said in an interview: "We responded to FDA on Aug. 16 with our plan to bring our operation into compliance with regulations." Doc. 9302W The Aug. 22 warning letter to Alfa Medical Equipment of Hempstead, NY, noted six deviations, including the lack of procedures for design controls. However, the two-pager gave up little in the way of detail. The agency also commented that Alfa had not documented "the reason for the change in design of the sterilizer sterilizer /ster·i·liz·er/ (ster´i-liz?er) an apparatus for the destruction of microorganisms. ster·il·iz·er n. An apparatus for rendering objects aseptic. heating unit" on an engineering change order form per company SOPs. In keeping with recent emphasis on managerial responsibility for quality systems requirements, FDA cited the maker of dry heat sterilizers for what it described as management's failure to "establish its policy and objectives for and commitment to quality as required" by regulations. The warning letter did not indicate any response by the firm to a 483. In an interview, Charles Fishelson, a partner and the firm's vice president, stated that "we expect FDA to be back by the end of the year and we have resolved all open issues." Doc. 9297W |
|
||||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion