FDA WARNING_LETTER - TYTEX SLOVAKIA S.R.O. - January 24, 2013

The FDA issued a Warning Letter to Tytex Slovakia S.R.O. following an inspection from January 21-24, 2013, at their Humenne, Slovakia facility. The inspection revealed that their Safehip AirX Textile Hip Protector devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), due to failures related to Medical Device Reporting (MDR) requirements under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803. Specific violations include the failure to report to FDA within 30 calendar days information suggesting a device may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1). Additionally, the firm failed to develop, maintain, and implement adequate written MDR procedures, as required by 21 CFR 803.17, with deficiencies noted in event identification, evaluation, and report transmission. A nonconformance with 21 U.S.C. § 351(h) and 21 CFR Part 820 was also identified, specifically the failure to establish and maintain adequate procedures for finished device acceptance to ensure products meet acceptance criteria, as required by 21 CFR 820.80(d), citing an instance where a non-conforming lot was released. The firm's responses to the FDA 483 were deemed inadequate for all violations. Tytex Slovakia S.R.O. is required to notify the FDA in writing within fifteen business days with specific corrective actions, a prevention plan, and documentation. The letter emphasizes that these violations may indicate serious systemic problems in their manufacturing and quality management systems, requiring a comprehensive investigation and prompt corrective actions.