FDA 483 - Join Parachute LLC
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Join Parachute, LLC in El Dorado, AR was inspected from June 22-23, 2023, and cited for a significant issue regarding donor reinstatement. The inspection found that a Corporate Responsible Physician, who was not licensed to practice medicine in Arkansas, reinstated multiple donors into the plasmapheresis program despite their prior deferral due to abnormal protein test results. This raises concerns about the qualifications of personnel making critical medical decisions for donor eligibility.
- Company
- Join Parachute LLC
- Product Type
- Biologics
ID · e497f0c8-f755-459d-8240-8a8aabd6e678