June 4, 2024

Jun

Warning Letter: CAPA Procedures Not Established

June 4, 2024Allison PateNews

WARNING LETTER Techlem Medical Corporation was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 671395 Techlem Medical Corporation Mississauga ON December 26, 2023 Inspection Dates: June 19, 2023, through June 22, 2023 Inspection Issue(s): These violations include, but are not limited to, the following: 1. Failure...

Jun

Warning Letter: Regulatory Classification

June 4, 2024Allison PateNews

WARNING LETTER Trexo Robotics Holdings, Inc. was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 673150 Cue Health, Inc. San Diego, CA February 7, 2024 Inspection Dates: on June 3 through June 5, 2023 Inspection Issue(s): “the Trexo devices are adulterated under section 501(f)(1)(B) of...

Jun

FDA Recall: Potential for Loss or Degradation of Image When Using Monitor with other Devices

June 4, 2024Allison PateNews

Company: Verathon, Inc. Date of Enforcement Report: 6/4/2024 Class II PRODUCT Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized Monitor Recall Number: Z-2021-2024 REASON: Due to software issues, there is the potential for loss of image or a degradation of the image when using the monitor with other connectable devices. RECALLING...

Warning Letter: CAPA Procedures Not Established

Warning Letter: Regulatory Classification

FDA Recall: Potential for Loss or Degradation of Image When Using Monitor with other Devices

SoftwareCPR Training Courses

Corporate Office

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Warning Letter: CAPA Procedures Not Established

Warning Letter: Regulatory Classification

FDA Recall: Potential for Loss or Degradation of Image When Using Monitor with other Devices

SoftwareCPR Training Courses

Corporate Office