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The FDA has issued a warning letter to Tokyo-based endoscope manufacturer Olympus Medical Systems for failing to establish procedures to implement corrective and preventative actions as well as a lack of process validation for product changes, among other lapses.
North Carolina-based Carolina Biological Supply was handed a Form 483 for lacking adequate procedures for corrective and preventative actions (CAPA), medical device reporting (MDR) and audits, among other lapses.
Having operational logistics in place for your FDA inspection means writing down the inspection plan beforehand in a standard operating procedure (SOP), starting with the moment the investigators walk in the door, advised inspection expert David Chesney, principal of DL Chesney Consulting, in a recent WCG FDAnews webinar.
The FDA handed Oak Ridge Products a Form 483 for a lack of design control documents as well as inadequate corrective and preventive action (CAPA) procedures and complaint handling, among other lapses.
Alfa Wassermann, a West Caldwell, N.J.-based provider of chemistry analyzers, was handed a Form 483 for device history record (DHR) issues, lack of proper procedures for use and removal of manufacturing materials, and other lapses following a September 2022 inspection by the FDA.
Dominion Aesthetics Technologies, maker of Eon, a fat-reducing laser device, received a Form 483 following a September 2022 inspection of its Winter Park, Fla., facility for failure to properly handle complaints, to establish procedures for corrective and preventive action (CAPA) and to follow procedure for design control, among other lapses.
Be sure you understand the investigator’s questions during an FDA inspection – and always ask for clarification if you are unclear, advised inspection expert David Chesney, principal of DL Chesney Consulting, in a recent WCG FDAnews webinar.
Missouri-based Hi-Dow International, a manufacturer of transcutaneous nerve stimulators (TENS) units, received a form 483 for several repeat observations of failure to establish proper complaint procedures, lack of design controls, and inadequate procedures for corrective and preventive actions, among other lapses.
Texas-based Dalton Medical, a manufacturer of powered wheelchairs, adjustable hospital beds and other durable medical equipment, received a Form 483 for failure to establish design control and complaint handling procedures, among other lapses.
It can help to learn more about an FDA inspection team ahead of time, said inspection expert David Chesney, principal of DL Chesney Consulting, in a recent WCG FDAnews webinar.
The FDA handed cardiac device manufacturer Atrium Medical a Form 483 after a July-August 2022 inspection of its facility in Merrimack, N.H., found inadequate design and process controls among other lapses described as repeated systemic deficiencies.
Devicemakers should err on the side of caution and open a Corrective and Preventive Action (CAPA) investigation even if they are unsure it’s required, said Judith Meritz, life sciences regulatory consultant with Meritz & Muenz, in a recent WCG FDAnews webinar.