Company: SeQual Technologies Inc.
Date: 7/18/01
Product: Oxygen

Failure to ensure that a process whose results cannot be fully verified by subsequent inspection and testing, has been validated and approved according to established procedures [21 CFR 820.75(a)]. Specifically, your firm has no documented evidence that provides a high degree of assurance that the manufacturing specifications and processing controls used in the automated and software controlled adhesive operations of your manifold and port plate subassemblies of your oxygen concentrators will consistently produce a product meeting its pre-determined specifications and quality attributes (traditionally termed validation).

FDA District: Los Angeles