PremiumEStore LLC. dba Premium-PPESeptember 17, 2024

FDA 483 - PremiumEStore LLC. dba Premium-PPE - September 17, 2024

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Record Details

PremiumEStore LLC, dba Premium-PPE, a manufacturer in Virginia Beach, VA, was cited for two significant observations during an FDA inspection. The firm failed to adequately establish and implement procedures for finished device acceptance, including proper documentation of inspection failures and verification of all product specifications. Additionally, the inspection revealed deficiencies in the firm's non-conformance procedures, with multiple non-conforming product issues lacking documented investigation, inspection, or disposition.

Company: PremiumEStore LLC. dba Premium-PPE
Inspection Date: September 17, 2024
Product Type: Device
Office: Baltimore District Office
Person: Tiki Dixon

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ID · 3594a9d3-3b5c-437e-b605-50769146845f