Ultradent Products, Inc.
Overview
Ultradent Products, Inc. is a medical device company headquartered in South Jordan, United States, founded in 1978, with 1,001-5,000 employees.
API / Drug Master Files
Ultradent Products, Inc. holds 0 active (1 total) FDA Type II Drug Master File — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- STERILE PROCESSING FACILITIES FOR CEFAZOLIN SODIUM STERILE, (BULK) AS LOCATED IN FUJI, JAPANInactive1991-03-04
FDA compliance signals
9 FDA enforcement records linked to this company.
- 4832025-06-13
Scientifically sound laboratory controls
- 4832025-06-13
No written record of investigation
- 4832025-06-13
Written procedures not established/followed
- 4832020-01-17
Scientifically sound laboratory controls
- 4832020-01-17
Following/documenting laboratory controls
- 4832020-01-17
Test methods
- 4832017-09-15
Buildings not maintained in good state of repair
- 4832014-09-12
Control procedures to monitor and validate performance
- 4832014-09-12
Written record of investigation incomplete
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