# FDA 483 - Join Parachute LLC - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/join-parachute-llc/e497f0c8-f755-459d-8240-8a8aabd6e678

> FDA 483 for Join Parachute LLC on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Join Parachute LLC
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

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Company: https://www.globalkeysolutions.net/companies/join-parachute-llc/426a180a-82cf-4faf-9673-d48143bc558d

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd