483
Surgisil, LLPFDA 483 - Surgisil, LLP
Record Details
An FDA inspection of SurgiSil, LLP in Plano, TX, a device manufacturer, revealed significant deficiencies in its quality system. Observations included failures to implement and verify corrective and preventive actions, lack of regular quality audits, and inadequate employee training procedures. These issues indicate a breakdown in the firm's ability to maintain an effective quality system.
- Company
- Surgisil, LLP
- Product Type
- Device
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ID · a580d576-c60c-42d3-bc04-d4d545c79b6e