FDA WARNING_LETTER - Tecres S.p.A. - February 05, 2015

On February 2-5, 2015, an FDA inspection of Tecres S.p.A. in Sommacampagna, Italy, revealed that their bone cement devices and antibiotic-containing temporary spacers are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). A February 20, 2015, response from Tecres was reviewed; subsequent responses were not.

Violations include: 1. Failure to validate the molding and finishing processes for temporary knee (Spacer K) and hip (Spacer G) implants, as required by 21 CFR 820.75(a). Tecres' response indicated a plan to validate but lacked completion documentation. 2. Failure to validate Excel worksheets used in device design validation, specifically "(b)(4)" and "(b)(4)," violating 21 CFR 820.30(g). Tecres' response indicated a plan to validate but lacked completion documentation. 3. Failure to establish and maintain adequate finished device acceptance procedures with documented acceptance criteria for critical attributes like holes, pits, cracks, and foreign material, as required by 21 CFR 820.80(d). Tecres' response did not address this.

Additionally, devices are misbranded under 2