Warning letters emphasize the importance of being able to generate and control adequate records when an FDA inspector comes for an inspection.


Our latest round of warning letters emphasize the importance of being able to generate and control adequate records so that you can produce reports when an FDA inspector is drumming his fingers on your desk during an inspection.

Medsource, a Rhode Island-based of orthopedic surgical instrument trays, was hit by the agency for not conforming to current Good Manufacturing Practice (cGMP) requirements regarding manufacture, packing, storage, or installation.

In addition to being unable to produce a CAPA procedure or acceptance activities when asked by the FDA investigator, Medsource allegedly failed to establish procedures whereby senior staff was engaged enough with quality system issues. Those charges came in a September 24 letter, based on inspections toward the end of March.

Nearby, Albany-based CMP Industries felt the after effects of inspections conducted in April and May. In a September 9 letter, FDA challenged the maker of the Impak Elastic Acrylic Resin Liquid and Impak Repair Acrylic Reisin, used to repair dentures, over a number of issues. In addition to the seemingly ubiquitous CAPA, FDA also didn’t like what it saw when it kicked the tires of CMP’s design controls.

FDA’s Ohio inspectors spent the month of June rooting around Troy Innovative Instrument’s Middlefield offices. They found a few things they didn’t like: adulterated devices, failure to validate a number of manufacturing processes, weak documentation, and failure to adequately control nonconforming products. Troy makes various tools and implantable orthopedic devices, including trocars, lumbar bone screws, rods, nuts, and plates.

In an August 27 warning letter, FDA cited Ultroid Technologies for inadequate methodology regarding facilities or controls used for manufacturing, packaging, storage, or installation its devices which include the Ultroid Hemorrhoid Management System and Procedure Kit accessory.

FDA didn’t like Ultroid’s CAPA program, its failure to establish and maintain adequate procedures in a number of areas including work operations and quality issues, or its inability to establish procedures to ensure that all purchases or otherwise received product conform to specified requirements.

Finally, FDA reported back from a series of investigations in March at Cellestis, based in Santa Clarita, California. Cellestis probably didn’t like the FDA’s opinion that it wasn’t handling complaints properly with a formally designated unit. The agency also called the firm out for failing to adequately develop, maintain, and implement written medical device record (MDR) requirements. Cellestis manufactures a test designed to diagnose or help cure, mitigate or otherwise treat diseases impacting the body.

About AssurX, Inc.
AssurX, Inc. provides global companies with enterprise quality management systems and regulatory compliance software solutions. AssurX’s flexible, all-in-one system automates quality and compliance related processes so issues can be centrally managed—from detection to corrective action and trend analysis. It helps collect, organize, analyze and share information to better manage risk and improve quality and compliance performance everywhere in the enterprise.

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