FDA WARNING_LETTER - Kentron Health Care, Inc. - October 12, 2011

On October 5-7 and 11-12, 2011, the FDA inspected Kentron Health Care, Inc., a manufacturer of non-surgical isolation gowns. The inspection revealed the firm's devices are misbranded under Section 502(t)(2) of the Act due to failure to furnish required information under Section 519 and 21 CFR Part 803 (Medical Device Reporting - MDR).

Key violations include: 1. **Failure to develop, maintain, and implement written MDR procedures (21 CFR 803.17(a))**: The MDR procedure lacked definitions for reportable events, a standardized review process for determining reportability (e.g., no instructions for event investigation or clear decision-maker for reporting), and instructions for timely transmission of complete reports (e.g., how to obtain/complete FDA Form 3500A, circumstances for initial/supplemental/follow-up reports, submission address). The procedure also referenced outdated "Baseline Reports." The firm's response, stating modifications would take 90-120 days, was deemed inadequate as it lacked specific revisions or an updated procedure.

Additional quality system deficiencies (21 CFR 820) include: 2. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: No written procedures or analysis of