483
Active MedicalFDA 483 - Active Medical - December 12, 2019
Record Details
Restore Medical in Sandy, UT, an HCT/P storage and distributor, was cited for significant deficiencies during an FDA inspection. Observations included a failure to record and review HCT/P storage temperatures, lack of established and approved procedures for handling HCT/Ps, and an absence of a formal personnel training program. These issues indicate a lack of adequate controls and documentation for critical operations.
- Office
- Denver District Office
- Person
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ID · 92f24b8b-9c7a-4bdd-837c-e2c181a37e91