Cretex Companies has acquired Quality Tech Services (QTS). Cretex Companies Inc. CEO Lynn Schuler says, “By adding QTS’s capabilities, we’ve made Cretex Medical an even better outsource partner for medical device companies.”
Located in Bloomington, Minnesota, QTS specializes in cleanroom assembly, packaging and labeling, sterilization management, process development and validations, and material sourcing and supply chain management, serving a broad set of original equipment manufacturers (OEMs) in the orthopedic, neurology, pulmonary, dental, and other medical device markets.
FDA warns three firms regarding quality issues
The FDA issued warnings to three device manufacturers for failures in good manufacturing practices (GMPs), validations, medical device reporting (MDR), and other quality-related areas.
International Medsurg Connection was warned that its Schaumburg, Illinois, facility lacked proper procedures to ensure hypodermic syringes met specifications by releasing syringes without appropriate sample-size testing.
Oxford Performance Materials received a warning following a March/April inspection which discovered a failure to validate cleaning of several of its implants – receiving at least one complaint regarding a contaminated cranial implant.
Vidco was cited for validation of changes and other deviations following a January inspection of its Beaverton, Oregon, facility. The firm failed to develop procedures for validating device design use by altering software in its monitoring devices to add internal speakers to provide alarms.