ETS WOUND CARE LLCJune 17, 2025

FDA 483 - ETS WOUND CARE LLC - June 17, 2025

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ETS WOUND CARE LLC in Rolla, MO, was inspected from June 16-17, 2025, and received one observation. The firm failed to adequately validate a design change for sterile packaging, specifically regarding the sterilization process's effect on package integrity and strength. This indicates a significant concern with process validation for critical medical device components.

Company: ETS WOUND CARE LLC
Inspection Date: June 17, 2025
Product Type: Other
Office: Kansas City District Office
Person: Edward E. Lockwood

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ID · fe6f88d5-cb85-412d-bc7b-ca2114343a00