WARNING LETTER Robbins Instruments, LLC was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 687984 2003 Edwards Street Houston, TX 77007 United States Dates: March 27 through May 31, 2024 Inspection Issue(s): The report states that, “FDA has learned that your firm is marketing the Dermo-Jet Needleless...Read More

WARNING LETTER Becton, Dickinson, and Company/CareFusion was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 691601 Becton, Dickinson, and Company/CareFusion 303, Inc. 1 Becton Drive Franklin Lakes, NJ 07417United States Dates: May 6, 2024 through May 22, 2024 Inspection Issue(s): Report states, “your firm manufactures Pyxis Medication...Read More

WARNING LETTER Rolence Ent. Inc. was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 695010 Rolence Ent. Inc. No. 18-3, Lane 231 Pu Chung Road Taoyuan District, Taoyuan City 32083 Taiwan Dates: July 8, 2024, through July 11, 2024 Inspection Issue(s): Report states, “This inspection revealed that...Read More

WARNING LETTER Micro-X Ltd. was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 692084 Micro-X Ltd.. 6 MAB Eastern Promenade, Unit 14Tonsley SA 5042Australia Dates:  May 20, 2024, through May 23, 2024 Inspection Issue(s): The report states, “This inspection revealed that these devices are adulterated within the...Read More

WARNING LETTER Globus Medical, Inc. was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 685606 Globus Medical, Inc. Valley Forge Business Center2560 General Armistead Avenue Audubon, PA 19403 Dates: February 15, 2024, through March 7, 2024 Inspection Issue(s): These violations include, but are not limited to, the...Read More

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...Read More

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...Read More