483
Essential Safety PPEFDA 483 - Essential Safety PPE
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Record Details
An FDA inspection of Essential Safety PPE in Houston, TX, a device manufacturer, revealed significant deficiencies in their quality system. The firm failed to conduct required management reviews and internal quality audits in 2023. Additionally, issues were noted with document change records and the availability of non-conformance reports during the inspection.
- Company
- Essential Safety PPE
- Product Type
- Device
- Office
- Dallas District Office
- Person
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ID · 286029f2-e31b-45da-8e18-38a5c49b7977