FDA WARNING_LETTER - Linet Spol. S.r.o. - November 01, 2012

On October 29 - November 1, 2012, an FDA inspection of Linet Spol. S.r.o. in Slany, Czech Republic, identified significant violations regarding their AC powered adjustable hospital beds (Eleganza 3, MultiCare, Eleganza EZ). These devices were deemed misbranded under section 502(t)(2) of the Act for failing to furnish required information under section 519 and 21 CFR Part 803 (Medical Device Reporting).

The firm failed to develop, maintain, and implement written MDR procedures (21 CFR 803.17), lacking systems for timely identification, communication, and evaluation of reportable events. Their submitted procedure was inadequate, missing definitions for "become aware," "caused or contributed," and "reasonably known."

Additionally, the inspection revealed quality system deficiencies under 21 CFR Part 820: 1. Failure to establish and maintain complaint handling procedures (21 CFR 820.198(a)), lacking requirements for uniform processing, investigation records, and comprehensive investigation scope. The firm's response was inadequate, with proposed changes not fully implemented or retrospectively reviewed. 2. Failure to maintain records of document changes (21 CFR 820.40(b)), with uninitialed/undated corrections and use of white-out on batch records. The response was