FDA WARNING_LETTER - Unomedical s.r.o. - February 06, 2014

The FDA issued a Warning Letter to Unomedical s.r.o. in Michalovce, Slovakia, following a February 3-6, 2014, inspection. The inspection revealed that the firm's urology catheters are adulterated under section 501(h) of the Act because their manufacturing, packing, storage, or installation methods, facilities, or controls do not conform with the Quality System regulation (21 CFR Part 820). Key violations include failures to establish and maintain procedures for monitoring and controlling validated process parameters (21 CFR 820.75(b)), controlling environmental conditions and inspecting systems (21 CFR 820.70(c)), reviewing and revalidating processes when changes occur (21 CFR 820.75(c)), defining control over suppliers (21 CFR 820.50(a)(2)), and ensuring adequate sampling methods with statistical rationale (21 CFR 820.250(b)). The firm's February 26, 2014, response to the FDA 483 was deemed inadequate as supporting documentation for planned corrective actions, such as CAPAs, procedure revisions, and audits, was not provided for review. The FDA requires a written response within fifteen business days detailing specific, systemic corrective actions, preventative measures, and a timetable for implementation, with documentation. Failure to correct these violations could impact federal contracts and premarket approval for Class III devices.