Latest FDA Warning Letters

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

Datascope Corp. Fairfield, NJ (9/11): FDA inspected the firm in June and cited GMP violations for medical devices. For example, the firm failed to maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. The firm also failed to timely report to FDA information that reasonably suggests that a device may have caused or contributed to a death or serious injury.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm621899.htm

Sofie Biosciences Culver City, CA (9/24): FDA inspected the firm in February and cited significant GMP violations for positron emission tomography (PET) drugs. For example, the firm failed to take corrective actions following bacterial contamination of an injectable product batch that was released. The firm’s facilities were not adequate to ensure the prevention of contamination of equipment or product by environmental conditions that could reasonably be expected to have an adverse effect on product quality.https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm621596.htm