Overview
Sofie is a pharmaceutical company headquartered in Dulles, United States, founded in 2008, with 201-500 employees.
FDA compliance signals
42 FDA enforcement records linked to this company.
- 4832026-01-15
Determination need for investigation
- 4832026-01-15
Record quality
- 4832025-10-28
Determination need for investigation
- 4832025-10-28
Personnel not qualified
- 4832025-10-28
Orderly handling, prevention of mix-ups, prevention of contamination
- 4832025-10-28
Adequate controls (general)
- 4832025-09-03
Adequate controls (general)
- 4832025-08-28
Equipment procedures
- 4832025-08-07
Personnel not qualified
- 4832025-08-07
Data and documentation review
- 4832025-08-07
Equipment procedures
- 4832025-07-25
Conform to specs prior to release
- 4832025-07-25
Written QA procedures established, followed
- 4832024-01-22
Adequate controls (general)
- 4832024-01-22
Orderly handling, prevention of mix-ups, prevention of contamination
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