Medsource, Ultroid, St. Jude Medical Warned by FDA

Manufacturing quality violations, lack of premarket clearance, failure to register manufacturing facilities and failure to adequately develop medical device reporting procedures were issues covered in warning letters the FDA recently issued to medical device firms.

In a letter posted to the Food and Drug Administration’s website Sept. 29, the agency warned orthopedic surgical instrument trays maker Medsource Inc. about four categories of manufacturing quality violations that FDA inspectors discovered during an inspection at the Tiverton, R.I.-based facility.

The letter, dated Sept. 24, and signed by Amber Wardwell, acting district director of the FDA’s New England District Office, said Medsource ...