Lack of CAPA tip of iceberg for Health Care. (Medical Devices).A lack of corrective cor·rec·tive adj. Counteracting or modifying what is malfunctioning, undesirable, or injurious. n. An agent that corrects. corrective, n and preventative action procedures netted Health Care Manufacturing, Inc. an Oct. 18 warning letter. "Your firm does not possess procedures for implementing corrective and preventative action that include requirements to analyze work operations, quality audit reports, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems," the letter stated. The letter also cited the Springfield, MO-based manufacturer of X-ray X-ray Electromagnetic radiation of extremely short wavelength (100 nanometres to 0.001 nanometre) produced by the deceleration of charged particles or the transitions of electrons in atoms. systems, electrical muscle stimulators electrical muscle stimulator Mainstream medicine A device that stimulates muscle contraction by electrical impulses; these devices are used in mainstream physical therapy to ↓ muscle spasms, prevent development of blood clots after surgery or CVAs, and chiropractic chiropractic (kīrəprăk`tĭk) [Gr.,=doing by hand], medical practice based on the theory that all disease results from a disruption of the functions of the nerves. tables with failure to establish procedures for management with executive responsibility to review the suitability and effectiveness of quality systems. The agency continued to cite the firm noting it failed to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints; failed to establish and maintain procedures for servicing medical devices; among other complaints. An unnamed investigator of the Kansas City Kansas City, two adjacent cities of the same name, one (1990 pop. 149,767), seat of Wyandotte co., NE Kansas (inc. 1859), the other (1990 pop. 435,146), Clay, Jackson, and Platte counties, NW Mo. (inc. 1850). District inspected the facility Sept. 3-6. The firm did not return calls seeking comment. Doc. 12068W |
|
||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion