Bracco Diagnostics Inc.
Overview
Bracco Diagnostics Inc. is a subsidiary of Bracco Group, an Italian multinational active in the healthcare sector. The company specializes in diagnostic imaging, offering a range of products and solutions for X-ray, MRI, and ultrasound imaging.
Therapeutic areas
FDA compliance signals
26 FDA enforcement records linked to this company.
- 4832024-11-27
Failure to develop written procedures
- 4832024-11-27
Late submission of 15-day report
- recall — Class II2018-04-04
Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
- 4832017-06-05
Late submission of 15-day report
- 4832014-05-30
Failure to develop written procedures
- 4832014-05-30
Written control procedures
- recall — Class III2014-02-19
Failed Stability Testing: This product is below specification for preservative content.
- recall — Class III2013-08-28
Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.
- recall — Class II2013-08-21
Presence of foreign substance: One lot of the product may contain black foreign particles
- 4832013-06-13
Written specifications - components
- 4832013-06-13
Review of representative number of batches
- 4832013-06-13
input/output verification
- 4832013-06-13
Investigations of discrepancies, failures
- 4832013-06-13
Written QA procedures established, followed
- 4832013-06-13
Procedures not in writing, fully followed
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