Pegasus Research CorporationApril 7, 2021

FDA 483 - Pegasus Research Corporation - April 07, 2021

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Record Details

Pegasus Research Corporation in Santa Ana, CA, was inspected regarding its manufacturing practices. The inspection revealed significant deficiencies in the firm's design control procedures, specifically the lack of validation, verification, and review for design changes to its Nebulizer Heater Adaptor Top. This indicates a serious lapse in quality system requirements for medical device manufacturing.

Company: Pegasus Research Corporation
Inspection Date: April 7, 2021
Product Type: Device
Office: Division of Pharmaceutical Quality Operations IV
Person: Kevin N. Tran

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ID · db480280-cf3c-46d5-b2c1-03983de244fc